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A Study of Lasmiditan on the Heart in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03465436
Collaborator
CoLucid Pharmaceuticals (Industry)
56
Enrollment
1
Location
4
Arms
3.1
Actual Duration (Months)
17.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Repolarization Duration as Well as Other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) With Those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects
Actual Study Start Date :
Sep 16, 2011
Actual Primary Completion Date :
Dec 20, 2011
Actual Study Completion Date :
Dec 20, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 100 milligrams (mg) Lasmiditan

A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods.

Drug: Lasmiditan
100 mg administered orally (PO)
Other Names:
  • LY573144

    		•
    Experimental: 400 mg Lasmiditan

    A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods.

    Drug: Lasmiditan
    400 mg administered PO
    Other Names:
  • LY573144

    		•
    Placebo Comparator: Placebo

    Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods.

    Drug: Placebo
    Placebo administered for lasmiditan or moxifloxacin
    Active Comparator: Moxifloxacin

    A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.

    Drug: Moxifloxacin
    400 mg moxifloxacin administered PO

    Outcome Measures

    Primary Outcome Measures

    1. Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.

    Secondary Outcome Measures

    1. Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.

    2. Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves.

    3. Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles.

    4. Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      Heart rate was determined during ambulatory blood pressure monitoring (ABPM).

    5. Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist

    6. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.

    7. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan [Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose]

      Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Body mass index within 18.5 and 29.9 kilograms per meter squared (kg/m²)

    • In good physical and mental health as determined by the following:

    • Complete medical history

    • Complete physical examination

    • Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature

    • Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring

    • Clinical laboratory tests

    Exclusion Criteria:

    • Any of the following cardiac abnormalities on safety screening ECG:

    • QTcF interval >430 milliseconds (ms) for males, >450 ms for females

    • Unusual T wave morphology or flattened low voltage T waves

    • PR interval >240 ms or <110 ms

    • Second-degree or third-degree atrioventricular block

    • ECG evidence of complete left or right bundle branch block

    • Intraventricular conduction delay or QRS duration >110 ms

    • Supine resting heart rate <45 beats per minute (bpm) or >90 bpm

    • Pathological Q-waves

    • Evidence of ventricular pre-excitation

    • Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease

    • Participants with a family history of Long QT syndrome

    • History of allergic hypersensitivity to lasmiditan or any component of the formulations

    • History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse

    • Participants with a history of postural hypotension or fainting

    • Participant is not able to understand and comply with study requirements, instructions and study restrictions

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. Berlin Germany 14050

    Sponsors and Collaborators

    • Eli Lilly and Company
    • CoLucid Pharmaceuticals

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03465436
    Other Study ID Numbers:
    • 16900
    • H8H-CD-LAHP
    • COL-MIG-105
    • 2011-003229-88
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Jan 31, 2020
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Moxifloxacin
    Lasmiditan

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title Sequence 1 ABDC Sequence 2 BCAD Sequence 3 CDBA Sequence 4 DACB
    Arm/Group Description Day 1 of each treatment period with a washout period of 7-14 days. A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched Day 1 of each treatment period with a washout period of 7-14 days. B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) Day 1 of each treatment period with a washout period of 7-14 days. C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO Day 1 of each treatment period with a washout period of 7-14 days. D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO
    Period Title: Period 1
    STARTED 14 14 14 14
    Received at Least 1 Dose of Study Drug 14 14 14 14
    COMPLETED 14 14 13 14
    NOT COMPLETED 0 0 1 0
    Period Title: Period 1
    STARTED 14 14 13 14
    Received at Least 1 Dose of Study Drug 14 13 13 14
    COMPLETED 14 13 13 14
    NOT COMPLETED 0 1 0 0
    Period Title: Period 1
    STARTED 14 13 13 14
    Received at Least One Dose of Study Drug 13 12 13 14
    COMPLETED 13 12 13 14
    NOT COMPLETED 1 1 0 0
    Period Title: Period 1
    STARTED 13 12 13 14
    Received at Least 1 Dose of Study Drug 13 12 13 14
    COMPLETED 13 12 12 14
    NOT COMPLETED 0 0 1 0

    Baseline Characteristics

    Arm/Group Title Sequence 1 ABDC Sequence 2 BCAD Sequence 3 CDBA Sequence 4 DACB Total
    Arm/Group Description Day 1 of each treatment period with a washout period of 7-14 days. A. 100 mg lasmiditan PO B. 400 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) C. Placebo matched Day 1 of each treatment period with a washout period of 7-14 days. B. 400 mg lasmiditan PO C. Placebo matched A. 100 mg lasmiditan PO D. 400 mg moxifloxacin PO (plus placebo) Day 1 of each treatment period with a washout period of 7-14 days. C. Placebo matched D. 400 mg moxifloxacin PO (plus placebo) B. 400 mg lasmiditan PO A. 100 mg lasmiditan PO Day 1 of each treatment period with a washout period of 7-14 days. D. 400 mg moxifloxacin PO (plus placebo) A. 100 mg lasmiditan PO C. Placebo matched B. 400 mg lasmiditan PO Total of all reporting groups
    Overall Participants 14 14 14 14 56
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    40.6
    (12.3)
    38.4
    (11.7)
    37.5
    (10.8)
    40.7
    (9.1)
    39.3
    (10.8)
    Sex: Female, Male (Count of Participants)
    Female
    9
    64.3%
    7
    50%
    5
    35.7%
    6
    42.9%
    27
    48.2%
    Male
    5
    35.7%
    7
    50%
    9
    64.3%
    8
    57.1%
    29
    51.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    14
    100%
    14
    100%
    14
    100%
    14
    100%
    56
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    1
    7.1%
    0
    0%
    0
    0%
    1
    1.8%
    White
    13
    92.9%
    13
    92.9%
    14
    100%
    13
    92.9%
    53
    94.6%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    7.1%
    0
    0%
    0
    0%
    1
    7.1%
    2
    3.6%
    Region of Enrollment (Count of Participants)
    Germany
    14
    100%
    14
    100%
    14
    100%
    14
    100%
    56
    100%

    Outcome Measures

    1. Primary Outcome
    Title Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
    Description The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug and have evaluable QTcF data.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods 400 mg lasmiditan administered PO in 1 of 4 treatment periods Placebo administered PO in 1 of 4 treatment periods. Moxifloxacin administered PO in 1 of 4 treatment periods.
    Measure Participants 52 55 54 52
    30 minutes postdose
    -8.90
    (7.20)
    -9.27
    (6.29)
    -5.49
    (5.52)
    1.90
    (8.69)
    1 hour postdose
    -7.42
    (5.83)
    -4.58
    (8.13)
    -3.94
    (5.15)
    8.36
    (6.51)
    1.5 hours postdose
    -7.63
    (5.98)
    -3.07
    (7.91)
    -3.68
    (4.66)
    7.63
    (6.32)
    2 hours postdose
    -6.96
    (7.08)
    -1.12
    (8.10)
    -3.83
    (5.28)
    8.16
    (7.21)
    2.5 hours postdose
    -5.26
    (7.36)
    0.15
    (8.67)
    -2.89
    (4.99)
    8.12
    (7.15)
    3 hours postdose
    -2.81
    (6.95)
    2.06
    (8.18)
    -2.04
    (5.71)
    10.01
    (6.42)
    3.5 hours postdose
    -2.39
    (7.63)
    3.58
    (6.88)
    -1.85
    (4.59)
    10.37
    (7.09)
    4 hours postdose
    -2.12
    (6.89)
    4.77
    (7.49)
    -2.34
    (5.65)
    9.39
    (5.85)
    6 hours postdose
    -4.33
    (7.32)
    -0.18
    (7.38)
    -3.39
    (6.59)
    4.91
    (7.05)
    8 hours postdose
    -6.74
    (7.16)
    -1.84
    (7.82)
    -3.99
    (7.11)
    3.90
    (7.13)
    12 hours postdose
    -3.73
    (5.72)
    -0.41
    (6.99)
    -1.79
    (5.91)
    4.63
    (7.12)
    24 hours postdose
    0.74
    (7.51)
    0.38
    (7.06)
    0.45
    (6.18)
    6.61
    (7.91)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.50
    Confidence Interval (2-Sided) 90%
    -5.41 to -1.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.54
    Confidence Interval (2-Sided) 90%
    -5.18 to -1.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.10
    Confidence Interval (2-Sided) 90%
    -5.77 to -2.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.21
    Confidence Interval (2-Sided) 90%
    -5.14 to -1.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.46
    Confidence Interval (2-Sided) 90%
    -4.41 to -0.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.91
    Confidence Interval (2-Sided) 90%
    -2.84 to 1.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.62
    Confidence Interval (2-Sided) 90%
    -2.53 to 1.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.07
    Confidence Interval (2-Sided) 90%
    -1.84 to 1.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -1.06
    Confidence Interval (2-Sided) 90%
    -3.22 to 1.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.73
    Confidence Interval (2-Sided) 90%
    -4.88 to -0.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.05
    Confidence Interval (2-Sided) 90%
    -3.77 to -0.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.21
    Confidence Interval (2-Sided) 90%
    -1.90 to 2.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.83
    Confidence Interval (2-Sided) 90%
    -5.56 to -2.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.75
    Confidence Interval (2-Sided) 90%
    -2.75 to 1.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.45
    Confidence Interval (2-Sided) 90%
    -1.49 to 2.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 2.58
    Confidence Interval (2-Sided) 90%
    0.58 to 4.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 2.85
    Confidence Interval (2-Sided) 90%
    0.73 to 4.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 3.94
    Confidence Interval (2-Sided) 90%
    1.85 to 6.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 5.28
    Confidence Interval (2-Sided) 90%
    3.61 to 6.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 6.94
    Confidence Interval (2-Sided) 90%
    4.99 to 8.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 3.13
    Confidence Interval (2-Sided) 90%
    0.93 to 5.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 2.09
    Confidence Interval (2-Sided) 90%
    -0.23 to 4.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan
    Comments 12 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.37
    Confidence Interval (2-Sided) 90%
    -0.57 to 3.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.29
    Confidence Interval (2-Sided) 90%
    -2.21 to 1.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 7.32
    Confidence Interval (2-Sided) 90%
    5.03 to 9.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 12.28
    Confidence Interval (2-Sided) 90%
    10.47 to 14.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 11.27
    Confidence Interval (2-Sided) 90%
    9.54 to 13.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 11.92
    Confidence Interval (2-Sided) 90%
    9.97 to 13.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 10.98
    Confidence Interval (2-Sided) 90%
    9.17 to 12.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 11.99
    Confidence Interval (2-Sided) 90%
    10.10 to 13.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 12.19
    Confidence Interval (2-Sided) 90%
    10.32 to 14.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 11.68
    Confidence Interval (2-Sided) 90%
    9.83 to 13.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 8.24
    Confidence Interval (2-Sided) 90%
    6.10 to 10.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 7.87
    Confidence Interval (2-Sided) 90%
    5.66 to 10.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 6.35
    Confidence Interval (2-Sided) 90%
    4.32 to 8.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 6.13
    Confidence Interval (2-Sided) 90%
    3.88 to 8.38
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin
    Description The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for participant pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug and have evaluable QTcI data.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods. 400 mg lasmiditan administered PO in 1 of 4 treatment periods. Placebo administered PO in 1 of 4 treatment periods. Moxifloxacin administered PO in 1 of 4 treatment periods.
    Measure Participants 52 55 54 52
    30 minutes postdose
    -9.92
    (7.62)
    -10.56
    (8.00)
    -5.27
    (6.04)
    2.24
    (8.88)
    1 hour postdose
    -9.50
    (7.74)
    -6.90
    (8.98)
    -3.35
    (5.52)
    8.96
    (7.14)
    1.5 hours postdose
    -9.39
    (6.93)
    -4.73
    (8.29)
    -2.81
    (5.58)
    8.61
    (6.42)
    2 hours postdose
    -8.74
    (8.34)
    -2.65
    (8.56)
    -3.49
    (5.82)
    8.29
    (7.03)
    2.5 hours postdose
    -7.90
    (9.42)
    -1.80
    (8.84)
    -2.44
    (5.61)
    8.40
    (7.53)
    3 hours postdose
    -5.08
    (8.29)
    -0.13
    (8.63)
    -1.70
    (6.10)
    11.01
    (6.89)
    3.5 hours postdose
    -3.86
    (8.72)
    1.90
    (7.48)
    -1.67
    (5.01)
    11.43
    (7.38)
    4 hours postdose
    -3.25
    (8.07)
    3.27
    (8.44)
    -1.19
    (6.37)
    10.28
    (6.50)
    6 hours postdose
    -4.84
    (7.00)
    -1.27
    (6.65)
    -3.13
    (6.61)
    4.85
    (7.37)
    8 hours postdose
    -7.10
    (7.76)
    -3.08
    (8.23)
    -3.89
    (6.77)
    4.04
    (7.01)
    12 hours postdose
    -4.08
    (5.88)
    -0.64
    (6.86)
    -1.65
    (6.09)
    4.87
    (7.14)
    24 hours postdose
    1.60
    (6.84)
    0.45
    (6.85)
    0.81
    (6.22)
    6.74
    (8.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.49
    Confidence Interval (2-Sided) 90%
    -6.47 to -2.52
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.30
    Confidence Interval (2-Sided) 90%
    -7.18 to -3.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.70
    Confidence Interval (2-Sided) 90%
    -7.57 to -3.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.47
    Confidence Interval (2-Sided) 90%
    -6.64 to -2.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.53
    Confidence Interval (2-Sided) 90%
    -6.87 to -2.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.74
    Confidence Interval (2-Sided) 90%
    -4.90 to -0.59
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -1.74
    Confidence Interval (2-Sided) 90%
    -3.86 to 0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -1.66
    Confidence Interval (2-Sided) 90%
    -3.77 to 0.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -1.11
    Confidence Interval (2-Sided) 90%
    -3.17 to 0.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.47
    Confidence Interval (2-Sided) 90%
    -4.58 to -0.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.15
    Confidence Interval (2-Sided) 90%
    -3.87 to -0.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.79
    Confidence Interval (2-Sided) 90%
    -1.14 to 2.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.64
    Confidence Interval (2-Sided) 90%
    -6.57 to -2.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.49
    Confidence Interval (2-Sided) 90%
    -4.59 to -0.39
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.96
    Confidence Interval (2-Sided) 90%
    -3.02 to 1.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.64
    Confidence Interval (2-Sided) 90%
    -0.46 to 3.73
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.61
    Confidence Interval (2-Sided) 90%
    -0.59 to 3.81
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 2.41
    Confidence Interval (2-Sided) 90%
    0.25 to 4.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 4.30
    Confidence Interval (2-Sided) 90%
    2.48 to 6.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 5.15
    Confidence Interval (2-Sided) 90%
    3.02 to 7.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 2.77
    Confidence Interval (2-Sided) 90%
    0.75 to 4.79
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.75
    Confidence Interval (2-Sided) 90%
    -0.55 to 4.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.75
    Confidence Interval (2-Sided) 90%
    -0.19 to 3.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Non-Inferiority
    Comments The non-inferiority (NI) margin for Lasmiditan doses versus (vs) Placebo is 10 milliseconds.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.48
    Confidence Interval (2-Sided) 90%
    -2.44 to 1.48
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 7.07
    Confidence Interval (2-Sided) 90%
    4.72 to 9.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 11.81
    Confidence Interval (2-Sided) 90%
    9.94 to 13.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 10.95
    Confidence Interval (2-Sided) 90%
    9.16 to 12.74
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 11.50
    Confidence Interval (2-Sided) 90%
    9.5 to 13.43
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 10.81
    Confidence Interval (2-Sided) 90%
    8.9 to 12.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 12.35
    Confidence Interval (2-Sided) 90%
    10.42 to 14.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 12.65
    Confidence Interval (2-Sided) 90%
    10.76 to 14.54
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 11.17
    Confidence Interval (2-Sided) 90%
    9.23 to 13.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 8.12
    Confidence Interval (2-Sided) 90%
    6.02 to 10.22
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 8.10
    Confidence Interval (2-Sided) 90%
    6.01 to 10.19
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 6.26
    Confidence Interval (2-Sided) 90%
    4.23 to 8.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 5.74
    Confidence Interval (2-Sided) 90%
    3.47 to 8.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin
    Description ECGs were used to calculate cardiac intervals. The RR interval is the time between two R waves.
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug and have evaluable RR interval data.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods. 400 mg lasmiditan administered PO in 1 of 4 treatment periods. Placebo administered PO in 1 of 4 treatment periods. Moxifloxacin administered PO in 1 of 4 treatment periods.
    Measure Participants 52 55 54 52
    30 minutes postdose
    74.40
    (76.26)
    98.52
    (72.99)
    42.13
    (56.00)
    18.66
    (61.84)
    1 hour postdose
    149.22
    (77.73)
    153.15
    (65.13)
    49.87
    (62.40)
    9.63
    (63.32)
    1.5 hours postdose
    143.29
    (80.63)
    130.79
    (55.91)
    36.84
    (66.52)
    13.44
    (61.66)
    2 hours postdose
    118.39
    (60.84)
    128.10
    (48.50)
    44.69
    (53.70)
    26.01
    (54.44)
    2.5 hours postdose
    117.90
    (73.85)
    132.86
    (54.35)
    29.28
    (51.39)
    26.90
    (68.18)
    3 hours postdose
    105.56
    (63.82)
    119.52
    (60.66)
    30.84
    (57.28)
    24.87
    (66.41)
    3.5 hours postdose
    89.85
    (56.54)
    101.86
    (59.04)
    36.77
    (50.34)
    19.01
    (65.56)
    4 hours postdose
    72.22
    (57.19)
    83.00
    (56.84)
    30.32
    (51.11)
    13.64
    (68.55)
    6 hours postdose
    -26.01
    (69.03)
    -3.07
    (63.34)
    -88.95
    (60.15)
    -84.12
    (63.34)
    8 hours postdose
    5.63
    (73.58)
    29.01
    (66.89)
    -50.89
    (75.72)
    -49.70
    (52.21)
    12 hours postdose
    -26.70
    (77.94)
    5.19
    (73.16)
    -61.53
    (76.51)
    -74.80
    (70.71)
    24 hours postdose
    -16.37
    (68.00)
    -5.64
    (63.34)
    -11.66
    (60.48)
    -13.02
    (52.97)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 32.89
    Confidence Interval (2-Sided) 90%
    11.50 to 54.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 100.15
    Confidence Interval (2-Sided) 90%
    77.81 to 122.50
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 107.11
    Confidence Interval (2-Sided) 90%
    83.31 to 130.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 74.48
    Confidence Interval (2-Sided) 90%
    56.32 to 92.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 89.19
    Confidence Interval (2-Sided) 90%
    68.77 to 109.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 74.98
    Confidence Interval (2-Sided) 90%
    55.41 to 94.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 52.83
    Confidence Interval (2-Sided) 90%
    36.03 to 69.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 42.10
    Confidence Interval (2-Sided) 90%
    24.86 to 59.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 62.61
    Confidence Interval (2-Sided) 90%
    42.39 to 82.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 56.05
    Confidence Interval (2-Sided) 90%
    32.49 to 79.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 35.71
    Confidence Interval (2-Sided) 90%
    11.79 to 59.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.59
    Confidence Interval (2-Sided) 90%
    -24.66 to 15.47
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 56.53
    Confidence Interval (2-Sided) 90%
    36.72 to 76.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 103.30
    Confidence Interval (2-Sided) 90%
    83.88 to 122.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 94.21
    Confidence Interval (2-Sided) 90%
    75.15 to 113.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 83.49
    Confidence Interval (2-Sided) 90%
    67.98 to 99.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 103.64
    Confidence Interval (2-Sided) 90%
    87.28 to 120.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 89.26
    Confidence Interval (2-Sided) 90%
    71.24 to 107.29
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 65.29
    Confidence Interval (2-Sided) 90%
    48.28 to 82.30
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 52.85
    Confidence Interval (2-Sided) 90%
    36.10 to 69.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 86.09
    Confidence Interval (2-Sided) 90%
    66.36 to 105.82
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 80.12
    Confidence Interval (2-Sided) 90%
    58.32 to 101.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 67.58
    Confidence Interval (2-Sided) 90%
    44.64 to 90.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 7.77
    Confidence Interval (2-Sided) 90%
    -10.01 to 25.55
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -22.02
    Confidence Interval (2-Sided) 90%
    -38.44 to -5.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -38.87
    Confidence Interval (2-Sided) 90%
    -57.15 to -20.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -22.13
    Confidence Interval (2-Sided) 90%
    -39.35 to -4.91
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -17.35
    Confidence Interval (2-Sided) 90%
    -32.15 to -2.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -1.03
    Confidence Interval (2-Sided) 90%
    -18.17 to 16.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.77
    Confidence Interval (2-Sided) 90%
    -21.81 to 12.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -16.56
    Confidence Interval (2-Sided) 90%
    -33.36 to 0.24
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -15.29
    Confidence Interval (2-Sided) 90%
    -32.94 to 2.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 6.13
    Confidence Interval (2-Sided) 90%
    -10.86 to 23.11
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 2.27
    Confidence Interval (2-Sided) 90%
    -15.25 to 19.80
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -11.95
    Confidence Interval (2-Sided) 90%
    -33.46 to 9.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.31
    Confidence Interval (2-Sided) 90%
    -17.32 to 16.69
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin
    Description ECGs were used to calculate cardiac intervals. The QRS interval is the time the segment of the ECG that corresponds to depolarization of the ventricles.
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug and have evaluable QRS data.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods. 400 mg lasmiditan administered PO in 1 of 4 treatment periods. Placebo administered PO in 1 of 4 treatment periods. Moxifloxacin administered PO in 1 of 4 treatment periods.
    Measure Participants 52 55 54 52
    30 minutes postdose
    0.11
    (1.12)
    -0.10
    (1.23)
    0.09
    (1.28)
    -0.00
    (0.97)
    1 hours postdose
    -0.24
    (1.21)
    0.45
    (1.35)
    -0.02
    (1.20)
    -0.12
    (1.07)
    1.5 hours postdose
    -0.48
    (1.13)
    0.19
    (1.24)
    -0.37
    (1.06)
    -0.12
    (1.09)
    2 hours postdose
    -0.73
    (1.12)
    0.10
    (1.08)
    -0.30
    (1.22)
    -0.29
    (1.14)
    2.5 hours postdose
    -0.75
    (1.41)
    0.30
    (1.22)
    -0.21
    (1.08)
    -0.20
    (1.11)
    3 hours postdose
    -0.63
    (1.21)
    0.08
    (1.19)
    -0.26
    (1.19)
    -0.35
    (0.93)
    3.5 hours postdose
    -0.58
    (1.00)
    0.15
    (1.15)
    -0.17
    (0.98)
    -0.57
    (1.34)
    4 hours postdose
    -0.54
    (1.03)
    0.29
    (1.17)
    -0.20
    (0.95)
    -0.58
    (1.25)
    6 hours postdose
    0.20
    (1.43)
    0.64
    (1.50)
    0.73
    (1.34)
    0.13
    (1.39)
    8 hours postdose
    -0.41
    (1.36)
    -0.39
    (1.43)
    -0.28
    (1.38)
    -0.67
    (1.34)
    12 hours postdose
    0.34
    (1.46)
    0.24
    (1.67)
    0.63
    (1.05)
    0.32
    (1.52)
    24 hours postdose
    0.33
    (1.22)
    -0.07
    (1.22)
    -0.10
    (1.32)
    0.09
    (1.28)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.02
    Confidence Interval (2-Sided) 90%
    -0.37 to 0.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.23
    Confidence Interval (2-Sided) 90%
    -0.61 to 0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.12
    Confidence Interval (2-Sided) 90%
    -0.47 to 0.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.44
    Confidence Interval (2-Sided) 90%
    -0.81 to -0.07
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.55
    Confidence Interval (2-Sided) 90%
    -0.95 to -0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.38
    Confidence Interval (2-Sided) 90%
    -0.77 to 0.00
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.41
    Confidence Interval (2-Sided) 90%
    -0.72 to -0.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.35
    Confidence Interval (2-Sided) 90%
    -0.66 to -0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.54
    Confidence Interval (2-Sided) 90%
    -0.98 to -0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.14
    Confidence Interval (2-Sided) 90%
    -0.58 to 0.31
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.29
    Confidence Interval (2-Sided) 90%
    -0.70 to 0.12
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.43
    Confidence Interval (2-Sided) 90%
    0.01 to 0.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.19
    Confidence Interval (2-Sided) 90%
    -0.59 to 0.21
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.48
    Confidence Interval (2-Sided) 90%
    0.06 to 0.89
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.56
    Confidence Interval (2-Sided) 90%
    0.19 to 0.93
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.40
    Confidence Interval (2-Sided) 90%
    0.02 to 0.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.51
    Confidence Interval (2-Sided) 90%
    0.13 to 0.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.33
    Confidence Interval (2-Sided) 90%
    -0.05 to 0.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.32
    Confidence Interval (2-Sided) 90%
    -0.02 to 0.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.50
    Confidence Interval (2-Sided) 90%
    0.16 to 0.84
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.10
    Confidence Interval (2-Sided) 90%
    -0.56 to 0.36
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.11
    Confidence Interval (2-Sided) 90%
    -0.56 to 0.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.39
    Confidence Interval (2-Sided) 90%
    -0.84 to 0.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.04
    Confidence Interval (2-Sided) 90%
    -0.37 to 0.45
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.09
    Confidence Interval (2-Sided) 90%
    -0.45 to 0.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.10
    Confidence Interval (2-Sided) 90%
    -0.46 to 0.27
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.25
    Confidence Interval (2-Sided) 90%
    -0.10 to 0.60
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.01
    Confidence Interval (2-Sided) 90%
    -0.38 to 0.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.02
    Confidence Interval (2-Sided) 90%
    -0.34 to 0.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.09
    Confidence Interval (2-Sided) 90%
    -0.44 to 0.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.39
    Confidence Interval (2-Sided) 90%
    -0.76 to -0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.38
    Confidence Interval (2-Sided) 90%
    -0.73 to -0.03
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.60
    Confidence Interval (2-Sided) 90%
    -1.03 to -0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.39
    Confidence Interval (2-Sided) 90%
    -0.82 to 0.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.31
    Confidence Interval (2-Sided) 90%
    -0.70 to 0.09
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.19
    Confidence Interval (2-Sided) 90%
    -0.23 to 0.61
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin
    Description Heart rate was determined during ambulatory blood pressure monitoring (ABPM).
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug and have evaluable HR data.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods 400 mg lasmiditan administered PO in 1 of 4 treatment periods Placebo administered PO in 1 of 4 treatment periods. Moxifloxacin administered PO in 1 of 4 treatment periods.
    Measure Participants 52 55 54 52
    30 minutes postdose
    -3.90
    (5.05)
    -5.51
    (3.74)
    -2.41
    (3.22)
    -1.02
    (3.75)
    1 hour postdose
    -7.82
    (3.95)
    -8.40
    (3.21)
    -2.77
    (3.55)
    -0.42
    (4.05)
    1.5 hours postdose
    -7.55
    (4.16)
    -7.41
    (3.14)
    -2.01
    (3.53)
    -0.67
    (3.73)
    2 hours postdose
    -6.62
    (3.22)
    -7.30
    (2.93)
    -2.65
    (3.17)
    -1.52
    (3.19)
    2.5 hours postdose
    -6.49
    (4.07)
    -7.59
    (3.27)
    -1.75
    (2.97)
    -1.48
    (4.07)
    3 hours postdose
    -5.96
    (3.32)
    -6.82
    (3.53)
    -1.83
    (3.35)
    -1.26
    (3.95)
    3.5 hours postdose
    -5.26
    (3.02)
    -6.02
    (3.50)
    -2.32
    (3.06)
    -0.91
    (4.23)
    4 hours postdose
    -4.22
    (3.06)
    -5.02
    (3.42)
    -1.82
    (3.19)
    -0.55
    (4.37)
    6 hours postdose
    1.65
    (4.52)
    -0.10
    (3.77)
    6.29
    (5.18)
    5.84
    (4.84)
    8 hours postdose
    -0.43
    (4.73)
    -1.96
    (3.93)
    3.42
    (5.05)
    3.10
    (3.42)
    12 hours postdose
    1.58
    (5.31)
    -0.50
    (4.66)
    4.17
    (5.46)
    4.95
    (5.12)
    24 hours postdose
    1.01
    (4.45)
    0.42
    (4.09)
    0.89
    (3.96)
    0.81
    (3.60)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -1.53
    Confidence Interval (2-Sided) 90%
    -2.90 to -0.16
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.09
    Confidence Interval (2-Sided) 90%
    -6.29 to -3.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.57
    Confidence Interval (2-Sided) 90%
    -6.81 to -4.32
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.01
    Confidence Interval (2-Sided) 90%
    -5.00 to -3.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.78
    Confidence Interval (2-Sided) 90%
    -5.91 to -3.65
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.14
    Confidence Interval (2-Sided) 90%
    -5.20 to -3.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.94
    Confidence Interval (2-Sided) 90%
    -3.87 to -2.01
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.42
    Confidence Interval (2-Sided) 90%
    -3.42 to -1.42
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.61
    Confidence Interval (2-Sided) 90%
    -6.17 to -3.06
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.82
    Confidence Interval (2-Sided) 90%
    -5.38 to -2.26
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -2.65
    Confidence Interval (2-Sided) 90%
    -4.33 to -0.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection 100 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.12
    Confidence Interval (2-Sided) 90%
    -1.22 to 1.46
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 13
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.09
    Confidence Interval (2-Sided) 90%
    -4.16 to -2.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 14
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.61
    Confidence Interval (2-Sided) 90%
    -6.65 to -4.58
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 15
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.39
    Confidence Interval (2-Sided) 90%
    -6.42 to -4.35
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 16
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.64
    Confidence Interval (2-Sided) 90%
    -5.55 to -3.72
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 17
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.82
    Confidence Interval (2-Sided) 90%
    -6.77 to -4.87
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 18
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.99
    Confidence Interval (2-Sided) 90%
    -6.03 to -3.96
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 19
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.69
    Confidence Interval (2-Sided) 90%
    -4.68 to -2.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 20
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -3.19
    Confidence Interval (2-Sided) 90%
    -4.21 to -2.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 21
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -6.29
    Confidence Interval (2-Sided) 90%
    -7.83 to -4.95
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 22
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -5.37
    Confidence Interval (2-Sided) 90%
    -6.73 to -4.02
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 23
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -4.71
    Confidence Interval (2-Sided) 90%
    -6.25 to -3.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 24
    Statistical Analysis Overview Comparison Group Selection 400 mg Lasmiditan, Placebo
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.55
    Confidence Interval (2-Sided) 90%
    -1.74 to 0.63
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 25
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 30 minutes postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.32
    Confidence Interval (2-Sided) 90%
    0.32 to 2.33
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 26
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1 hour postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 2.29
    Confidence Interval (2-Sided) 90%
    1.19 to 3.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 27
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 1.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.30
    Confidence Interval (2-Sided) 90%
    0.31 to 2.28
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 28
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.07
    Confidence Interval (2-Sided) 90%
    0.17 to 1.97
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 29
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 2.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.21
    Confidence Interval (2-Sided) 90%
    -0.81 to 1.23
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 30
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.53
    Confidence Interval (2-Sided) 90%
    -0.50 to 1.56
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 31
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 3.5 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.36
    Confidence Interval (2-Sided) 90%
    0.29 to 2.44
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 32
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 4 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 1.21
    Confidence Interval (2-Sided) 90%
    0.09 to 2.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 33
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 6 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.49
    Confidence Interval (2-Sided) 90%
    -1.97 to 0.99
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 34
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 8 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.36
    Confidence Interval (2-Sided) 90%
    -1.54 to 0.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 35
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 12 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.73
    Confidence Interval (2-Sided) 90%
    -0.87 to 2.34
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 36
    Statistical Analysis Overview Comparison Group Selection Placebo, Moxifloxacin
    Comments 24 hours postdose
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value -0.12
    Confidence Interval (2-Sided) 90%
    -1.29 to 1.04
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    Title Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds
    Description ECGs were assessed for morphology abnormalities or changes in QTcf interval greater than 450 milliseconds by a board-certified cardiologist
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods. 400 mg lasmiditan administered PO in 1 of 4 treatment periods. Placebo administered PO in 1 of 4 treatment periods. Moxifloxacin administered PO in 1 of 4 treatment periods.
    Measure Participants 52 55 54 52
    Predose
    0
    0
    0
    0
    30 minutes postdose
    0
    0
    0
    1
    1 hour postdose
    2
    0
    0
    2
    1.5 hours postdose
    0
    1
    0
    2
    2 hours postdose
    1
    1
    0
    3
    2.5 hours postdose
    1
    1
    0
    2
    3 hours postdose
    1
    1
    0
    2
    3.5 hours postdose
    1
    2
    0
    3
    4 hours postdose
    1
    1
    0
    3
    6 hours postdose
    0
    0
    0
    0
    8 hours postdose
    0
    1
    0
    0
    12 hours postdose
    0
    0
    0
    0
    24 hours postdose
    0
    0
    0
    0
    7. Secondary Outcome
    Title Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan
    Description Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan.
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of lasmiditan.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods 400 mg lasmiditan administered PO in 1 of 4 treatment periods
    Measure Participants 52 55
    Mean (Standard Deviation) [nanogram per milliliter]
    104.55
    (41.452)
    526.15
    (240.997)
    8. Secondary Outcome
    Title Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan
    Description Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan.
    Time Frame Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of lasmiditan.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods 400 mg lasmiditan administered PO in 1 of 4 treatment periods
    Measure Participants 52 55
    Geometric Mean (Geometric Coefficient of Variation) [hours*nanogram per milliliter]
    684.66
    (278.258)
    3189.08
    (1152.338)

    Adverse Events

    Time Frame 75 days
    Adverse Event Reporting Description All randomized participants who received at least 1 dose of study drug.
    Arm/Group Title 100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Arm/Group Description 100 mg lasmiditan administered PO in 1 of 4 treatment periods. 400 mg lasmiditan administered PO in 1 of 4 treatment periods. Placebo administered PO in 1 of 4 treatment periods. Moxifloxacin administered PO in 1 of 4 treatment periods.
    All Cause Mortality
    100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/52 (0%) 0/55 (0%) 0/54 (0%) 0/52 (0%)
    Serious Adverse Events
    100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/52 (0%) 0/55 (0%) 0/54 (0%) 1/52 (1.9%)
    Infections and infestations
    Pilonidal cyst 0/52 (0%) 0 0/55 (0%) 0 0/54 (0%) 0 1/52 (1.9%) 1
    Other (Not Including Serious) Adverse Events
    100 mg Lasmiditan 400 mg Lasmiditan Placebo Moxifloxacin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/52 (40.4%) 33/55 (60%) 7/54 (13%) 9/52 (17.3%)
    Gastrointestinal disorders
    Nausea 4/52 (7.7%) 4 2/55 (3.6%) 2 0/54 (0%) 0 4/52 (7.7%) 4
    General disorders
    Asthenia 0/52 (0%) 0 4/55 (7.3%) 4 0/54 (0%) 0 0/52 (0%) 0
    Discomfort 0/52 (0%) 0 3/55 (5.5%) 3 0/54 (0%) 0 0/52 (0%) 0
    Infections and infestations
    Nasopharyngitis 1/52 (1.9%) 1 2/55 (3.6%) 2 2/54 (3.7%) 2 3/52 (5.8%) 3
    Musculoskeletal and connective tissue disorders
    Muscular weakness 0/52 (0%) 0 3/55 (5.5%) 3 0/54 (0%) 0 0/52 (0%) 0
    Nervous system disorders
    Dizziness 14/52 (26.9%) 18 23/55 (41.8%) 26 3/54 (5.6%) 4 0/52 (0%) 0
    Dysarthria 0/52 (0%) 0 3/55 (5.5%) 3 0/54 (0%) 0 0/52 (0%) 0
    Paraesthesia 5/52 (9.6%) 5 8/55 (14.5%) 8 0/54 (0%) 0 0/52 (0%) 0
    Restless legs syndrome 0/52 (0%) 0 3/55 (5.5%) 3 0/54 (0%) 0 0/52 (0%) 0
    Somnolence 13/52 (25%) 13 22/55 (40%) 22 3/54 (5.6%) 3 4/52 (7.7%) 4

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03465436
    Other Study ID Numbers:
    • 16900
    • H8H-CD-LAHP
    • COL-MIG-105
    • 2011-003229-88
    First Posted:
    Mar 14, 2018
    Last Update Posted:
    Jan 31, 2020
    Last Verified:
    Mar 1, 2018