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A Study of Galcanezumab in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02576951
Collaborator
(none)
178
Enrollment
1
Location
4
Arms
26.7
Actual Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are:

  • To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)

  • To measure how much of the Galcanezumab lyophilized (freeze dried) injectable formulation is absorbed into the blood stream and how long it takes the body to get rid of it compared to the Galcanezumab solution injectable formulation after a single injection under the skin (subcutaneous [SC]) (Part B).

Information about any side effects that may occur will also be collected. Each part of the study will last about six months. Participants may only enroll in one part.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
178 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Tolerability, Pharmacokinetics and Pharmacodynamics of LY2951742 in Healthy Subjects Following a Subcutaneous Administration of a Lyophilized Formulation or a Solution Formulation
Actual Study Start Date :
Oct 19, 2015
Actual Primary Completion Date :
Sep 3, 2016
Actual Study Completion Date :
Jan 8, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Galcanezumab Solution Formulation-Part A

Galcanezumab solution formulation in a prefilled syringe given SC once.

Drug: Galcanezumab
Administered SC
Other Names:
  • LY2951742

    		•
    Placebo Comparator: Placebo-Part A

    Placebo in a prefilled syringe given SC once.

    Drug: Placebo
    Administered SC
    Experimental: Galcanezumab Lyophilized Formulation-Part B

    Galcanezumab lyophilized (freeze dried) formulation given SC once.

    Drug: Galcanezumab
    Administered SC
    Other Names:
  • LY2951742

    		•
    Experimental: Galcanezumab Solution Formulation-Part B

    Galcanezumab solution formulation in a prefilled syringe given SC once.

    Drug: Galcanezumab
    Administered SC
    Other Names:
  • LY2951742

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Part A: Number of Participants With an Injection Site Adverse Event [Part A: Predose through 48 hours post dose]

      If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.

    2. Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab [Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.

    3. Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab [Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.

    Secondary Outcome Measures

    1. Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) [Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).

    2. Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) [Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).

    3. Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP [Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.

    4. Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP) [Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).

    5. Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP) [Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).

    6. Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP [Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose]

      Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Male and female healthy participants

    • Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive

    Exclusion Criteria:
    • Currently smoke in excess of 5 cigarettes/day

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Dallas Texas United States 75247

    Sponsors and Collaborators

    • Eli Lilly and Company

    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:
    NCT02576951
    Other Study ID Numbers:
    • 16084
    • I5Q-MC-CGAO
    First Posted:
    Oct 15, 2015
    Last Update Posted:
    Feb 26, 2019
    Last Verified:
    Feb 1, 2018

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 240 mg Galcanezumab Solution - Part A Placebo - Part A 300 mg Galcanezumab Lyophilized - Part B 300 mg Galcanezumab Solution - Part B
    Arm/Group Description Participants received 240 milligram (mg) Galcanezumab as a solution formulation by subcutaneous injection. Participants received placebo by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection
    Period Title: Overall Study
    STARTED 15 3 80 80
    Received at Least One Dose of Study Drug 15 3 80 80
    COMPLETED 14 3 78 75
    NOT COMPLETED 1 0 2 5

    Baseline Characteristics

    Arm/Group Title 240 mg Galcanezumab Solution - Part A Placebo - Part A 300 mg Galcanezumab Lyophilized - Part B 300 mg Galcanezumab Solution - Part B Total
    Arm/Group Description Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received placebo by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. Total of all reporting groups
    Overall Participants 15 3 80 80 178
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    49.5
    (12.1)
    45.7
    (14.5)
    38.5
    (11.4)
    40.6
    (12.8)
    40.5
    (12.44)
    Sex: Female, Male (Count of Participants)
    Female
    9
    60%
    3
    100%
    36
    45%
    38
    47.5%
    86
    48.3%
    Male
    6
    40%
    0
    0%
    44
    55%
    42
    52.5%
    92
    51.7%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    1
    6.7%
    0
    0%
    1
    1.3%
    0
    0%
    2
    1.1%
    Asian
    0
    0%
    0
    0%
    2
    2.5%
    2
    2.5%
    4
    2.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    5
    33.3%
    1
    33.3%
    43
    53.8%
    36
    45%
    85
    47.8%
    White
    8
    53.3%
    2
    66.7%
    30
    37.5%
    34
    42.5%
    74
    41.6%
    More than one race
    1
    6.7%
    0
    0%
    4
    5%
    8
    10%
    13
    7.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    United States
    15
    100%
    3
    100%
    80
    100%
    80
    100%
    178
    100%
    Basal Metabolic Index (BMI) (Kilogram per square meter) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kilogram per square meter]
    26.27
    (3.86)
    30.67
    (4.32)
    27.57
    (4.14)
    27.55
    (3.97)
    27.56
    (4.04)

    Outcome Measures

    1. Primary Outcome
    Title Part A: Number of Participants With an Injection Site Adverse Event
    Description If an injection site reaction is present, it will be fully characterized (including erythema, induration, pain, itching). A summary of other nonserious adverse event (AE), and all serious adverse events (SAE), regardless of causality, is located in the reported adverse events section.
    Time Frame Part A: Predose through 48 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug in Part A and had at least one post dose safety assessment.
    Arm/Group Title 240 mg Galcanezumab - Part A Placebo - Part A
    Arm/Group Description Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received placebo by subcutaneous injection.
    Measure Participants 15 3
    Count of Participants [Participants]
    3
    20%
    0
    0%
    2. Primary Outcome
    Title Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Infinity of Galcanezumab
    Description Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) from Time Zero to Infinity of Galcanezumab.
    Time Frame Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug in Part B and had evaluable AUC zero to infinity PK data.
    Arm/Group Title 300mg Galcanezumab Solution - Part B 300 mg Galcanezumab Lyophilized - Part B
    Arm/Group Description Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
    Measure Participants 78 79
    Geometric Mean (Geometric Coefficient of Variation) [day*microgram per milliliter(day*μg/mL)]
    1490
    (31)
    1670
    (32)
    3. Primary Outcome
    Title Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab
    Description Part B: Pharmacokinetics: Maximum Concentration (Cmax) of Galcanezumab.
    Time Frame Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug in part B and had evaluable Cmax PK data.
    Arm/Group Title 300 mg Galcanezumab Solution - Part B 300 mg Galcanezumab Lyophilized - Part B
    Arm/Group Description Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
    Measure Participants 78 79
    Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter (μg/mL)]
    38
    (30)
    42.4
    (28)
    4. Secondary Outcome
    Title Part A: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
    Description Part A: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).
    Time Frame Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part A.
    Arm/Group Title 240 mg Galcanezumab - Part A
    Arm/Group Description Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.
    Measure Participants 14
    Median (Full Range) [Days]
    56.01
    5. Secondary Outcome
    Title Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
    Description Part A: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC [0 to Tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).
    Time Frame Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable plasma AUC CGRP data in Part A.
    Arm/Group Title 240 mg Galcanezumab - Part A
    Arm/Group Description Participants received 240mg Galcanezumab as a solution formulation by subcutaneous injection.
    Measure Participants 14
    Geometric Mean (Geometric Coefficient of Variation) [day*ng/mL]
    231
    (48)
    6. Secondary Outcome
    Title Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
    Description Part A: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.
    Time Frame Part A: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part A.
    Arm/Group Title 240 mg Galcanezumab - Part A
    Arm/Group Description Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection.
    Measure Participants 14
    Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
    2.64
    (34)
    7. Secondary Outcome
    Title Part B: Pharmacodynamics (PD): Time to Maximum Concentration (Tmax) of Plasma Calcitonin Gene Related Peptide (CGRP)
    Description Part B: Pharmacodynamics (PD): Time to maximum concentration (tmax) of Plasma Calcitonin Gene Related Peptide (CGRP).
    Time Frame Part B: Predose, 8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable plasma Tmax CGRP data in Part B.
    Arm/Group Title 300 mg Galcanezumab Solution - Part B 300 mg Galcanezumab Lyophilized - Part B
    Arm/Group Description Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
    Measure Participants 78 79
    Median (Full Range) [Days]
    41.93
    41.95
    8. Secondary Outcome
    Title Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP)
    Description Part B: Pharmacodynamics (PD): Area Under the Concentration Versus Time Curve from time zero to tlast (AUC[0-tlast]) of Plasma Calcitonin Gene Related Peptide (CGRP).
    Time Frame Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable plasma AUC zero to tlast CGRP data in Part B.
    Arm/Group Title 300 mg Galcanezumab Solution - Part B 300 mg Galcanezumab Lyophilized - Part B
    Arm/Group Description Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
    Measure Participants 75 78
    Geometric Mean (Geometric Coefficient of Variation) [day*ng/mL]
    169
    (50)
    192
    (50)
    9. Secondary Outcome
    Title Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP
    Description Part B: Pharmacodynamics (PD): Maximum Concentration (Cmax) of Plasma CGRP.
    Time Frame Part B: Predose,8,24,48,96,120,168,216,264,336,504,672,1008,1344,1680,2016,2688,3360 hours post dose

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least one dose of study drug and had evaluable plasma Cmax CGRP data in Part B.
    Arm/Group Title 300 mg Galcanezumab Solution - Part B 300 mg Galcanezumab Lyophilized - Part B
    Arm/Group Description Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection.
    Measure Participants 78 79
    Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
    2.19
    (36)
    2.38
    (34)

    Adverse Events

    Time Frame Up to 20 Weeks
    Adverse Event Reporting Description All randomized participants.
    Arm/Group Title Galcanezumab 240 mg - Part A Placebo - Part A Galcanezumab 300 mg Lyophilized - Part B Galcanezumab 300 mg Solution - Part B
    Arm/Group Description Participants received 240 mg Galcanezumab as a solution formulation by subcutaneous injection. Participants received placebo by subcutaneous injection. Participants received 300 mg Galcanezumab as a lyophilized formulation by subcutaneous injection. Participants received 300 mg Galcanezumab as a solution formulation by subcutaneous injection.
    All Cause Mortality
    Galcanezumab 240 mg - Part A Placebo - Part A Galcanezumab 300 mg Lyophilized - Part B Galcanezumab 300 mg Solution - Part B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 0/3 (0%) 0/80 (0%) 0/80 (0%)
    Serious Adverse Events
    Galcanezumab 240 mg - Part A Placebo - Part A Galcanezumab 300 mg Lyophilized - Part B Galcanezumab 300 mg Solution - Part B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/15 (0%) 1/3 (33.3%) 1/80 (1.3%) 0/80 (0%)
    Cardiac disorders
    Atrial fibrillation 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Infections and infestations
    Cellulitis 0/15 (0%) 0 1/3 (33.3%) 1 0/80 (0%) 0 0/80 (0%) 0
    Other (Not Including Serious) Adverse Events
    Galcanezumab 240 mg - Part A Placebo - Part A Galcanezumab 300 mg Lyophilized - Part B Galcanezumab 300 mg Solution - Part B
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/15 (46.7%) 1/3 (33.3%) 25/80 (31.3%) 20/80 (25%)
    Blood and lymphatic system disorders
    Lymphadenopathy 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 2 0/80 (0%) 0
    Ear and labyrinth disorders
    Ear discomfort 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Ear pain 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Eye disorders
    Lacrimation increased 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 2/80 (2.5%) 2
    Abdominal pain upper 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Dental discomfort 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Diarrhoea 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 1/80 (1.3%) 1
    Dry mouth 0/15 (0%) 0 1/3 (33.3%) 1 0/80 (0%) 0 0/80 (0%) 0
    Nausea 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 1/80 (1.3%) 1
    Toothache 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Vomiting 0/15 (0%) 0 0/3 (0%) 0 2/80 (2.5%) 2 1/80 (1.3%) 1
    General disorders
    Chest pain 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 2 0/80 (0%) 0
    Facial pain 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Injection site erythema 1/15 (6.7%) 2 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Injection site pain 3/15 (20%) 4 0/3 (0%) 0 0/80 (0%) 0 2/80 (2.5%) 4
    Injection site pruritus 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Injection site swelling 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 2 0/80 (0%) 0
    Pain 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Pyrexia 0/15 (0%) 0 0/3 (0%) 0 2/80 (2.5%) 2 1/80 (1.3%) 1
    Vessel puncture site pain 1/15 (6.7%) 1 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Vessel puncture site reaction 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Immune system disorders
    Seasonal allergy 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Infections and infestations
    Bronchitis 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Fungal infection 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Furuncle 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Gastroenteritis 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Laryngitis 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Oral herpes 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Rhinitis 1/15 (6.7%) 1 0/3 (0%) 0 2/80 (2.5%) 2 2/80 (2.5%) 2
    Tonsillitis 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Upper respiratory tract infection 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 3/80 (3.8%) 3
    Urinary tract infection 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Viral upper respiratory tract infection 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Laceration 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Ligament sprain 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Procedural dizziness 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Procedural nausea 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Investigations
    Alanine aminotransferase increased 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Biopsy breast 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Physical breast examination abnormal 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 1/15 (6.7%) 1 0/3 (0%) 0 1/80 (1.3%) 1 1/80 (1.3%) 1
    Muscle spasms 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 3 1/80 (1.3%) 1
    Musculoskeletal stiffness 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Myalgia 0/15 (0%) 0 0/3 (0%) 0 2/80 (2.5%) 2 0/80 (0%) 0
    Neck pain 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Nervous system disorders
    Dizziness 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 1/80 (1.3%) 1
    Dysgeusia 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Headache 1/15 (6.7%) 1 0/3 (0%) 0 4/80 (5%) 4 3/80 (3.8%) 4
    Hypoaesthesia 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 1/80 (1.3%) 1
    Memory impairment 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Presyncope 1/15 (6.7%) 1 0/3 (0%) 0 0/80 (0%) 0 0/80 (0%) 0
    Psychiatric disorders
    Insomnia 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Libido decreased 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Reproductive system and breast disorders
    Dysmenorrhoea 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Respiratory, thoracic and mediastinal disorders
    Cough 0/15 (0%) 0 0/3 (0%) 0 2/80 (2.5%) 2 3/80 (3.8%) 3
    Dysphonia 0/15 (0%) 0 1/3 (33.3%) 1 0/80 (0%) 0 0/80 (0%) 0
    Laryngeal cyst 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Nasal congestion 1/15 (6.7%) 1 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Oropharyngeal pain 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 1/80 (1.3%) 1
    Rhinitis allergic 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Sinus congestion 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Throat irritation 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 2/80 (2.5%) 2
    Skin and subcutaneous tissue disorders
    Dermal cyst 0/15 (0%) 0 0/3 (0%) 0 0/80 (0%) 0 1/80 (1.3%) 1
    Rash 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 1/80 (1.3%) 2
    Swelling face 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0
    Vascular disorders
    Phlebitis 0/15 (0%) 0 0/3 (0%) 0 1/80 (1.3%) 1 0/80 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    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:
    NCT02576951
    Other Study ID Numbers:
    • 16084
    • I5Q-MC-CGAO
    First Posted:
    Oct 15, 2015
    Last Update Posted:
    Feb 26, 2019
    Last Verified:
    Feb 1, 2018