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A Study of LY2541546 in Healthy Postmenopausal Women

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01742078
Collaborator
(none)
60
Enrollment
2
Locations
9
Arms
24
Duration (Months)
30
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if a single dose of LY2541546 has any side effects on the body and to determine how long and how much LY2541546 stays in the bloodstream of the body.

Condition or Disease Intervention/Treatment Phase
  • Drug: LY2541546 - IV
  • Drug: LY2541546 - SC
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2541546 in Healthy Postmenopausal Women
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 7.5 mg LY2541546 - IV

Single dose of 7.5 mg LY2541546 administered intravenously (IV)

Drug: LY2541546 - IV
Administered IV
Other Names:
  • Blosozumab

    		•
    Experimental: 25 mg LY2541546 - IV

    Single dose of 25 mg LY2541546 administered IV

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    		•
    Experimental: 75 mg LY2541546 - IV

    Single dose of 75 mg LY2541546 administered IV

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    		•
    Experimental: 225 mg LY2541546 - IV

    Single dose of 225 mg LY2541546 administered IV

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    		•
    Experimental: 750 mg LY2541546 - IV

    Single dose of 750 mg LY2541546 administered IV

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    		•
    Experimental: 150 mg LY2541546 - SC

    Single dose of 150 mg LY2541546 administered subcutaneous (SC)

    Drug: LY2541546 - SC
    Administered SC
    Placebo Comparator: Placebo

    Single dose of placebo administered IV or SC

    Drug: Placebo
    Administered IV or SC
    Experimental: 225 mg LY2541546 - IV, OL

    Single dose of 225 mg LY2541546 administered IV, open label (OL)

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    		•
    Experimental: 750 mg LY2541546 - IV, OL

    Single dose of 750 mg LY2541546 administered IV, OL

    Drug: LY2541546 - IV
    Administered IV
    Other Names:
  • Blosozumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Day 1 through Day 85]

      An SAE is any AE from this study that results in one of the following outcomes: death initial or prolonged inpatient hospitalization a life-threatening experience (that is, immediate risk of dying) persistent or significant disability/incapacity congenital anomaly/birth defect or is considered significant by the investigator for any other reason.

    Secondary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546 [Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime]

    2. Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) [Baseline (predose), Day 29 anytime, Day 85 anytime]

      A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan.

    3. Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP) [Baseline (predose), Day 29 anytime, Day 85 anytime]

      N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model.

    4. Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies [Day 1: Predose, Day 29 anytime, Day 85 anytime]

      A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy postmenopausal females, as determined by medical history and physical examination

    • Body mass index (BMI) at screening between 19.0 and 32.0 kilograms per square meter (kg/m^2), inclusive

    • Acceptable Clinical laboratory test results, blood pressure and heart rate

    • Have given written informed consent

    • Additional Inclusion Criterion for Participants in Open Label Groups: Are currently taking or recently discontinued (not more than 3 months prior to study randomization) alendronate and have taken alendronate for at least 12 of the last 18 months

    Exclusion Criteria:

    • Within 30 days of the initial dose of study drug, have received treatment with a drug that has not received regulatory approval for any indication

    • Known allergies to LY2541546, its constituents, or related compounds

    • Persons who have previously participated in this study

    • History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders

    • History of or high risk for adverse outcome from bleeding, for example, transient ischemic attacks, cerebrovascular attacks, and ulcer disease

    • Paget's disease, parathyroid disease, or thyroid disease

    • Fracture of a long bone within 12 weeks of screening

    • Regular use of known drugs of abuse and/or positive findings on urinary drug screening

    • Evidence of human immunodeficiency virus (HIV), hepatitis C, hepatitis B and/or positive for anti-HIV antibodies, hepatitis C antibody, or hepatitis B surface antigen

    • Current use of therapies for osteoporosis or use of hormone replacement therapy (HRT) within the previous 12 months

    • Blood donation within the last month

    • Participants who have an average weekly alcohol intake that exceeds 14 units per week

    • Cigarette consumption of more than 10 cigarettes per day, or are unable or unwilling to refrain from nicotine during Clinical Research Unit (CRU) confinement

    Additional Exclusion Criterion for Participants in Double Blind Groups Only

    • Have received bisphosphonates during the previous 24 months.

    Additional Exclusion Criterion for Participants in Open Label Groups

    • Have received intravenous bisphosphonates within the previous 18 months

    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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician Evansville Indiana United States 47710
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician Indianapolis Indiana United States 46202

    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:
    NCT01742078
    Other Study ID Numbers:
    • 11952
    • I2M-MC-GSDA
    First Posted:
    Dec 5, 2012
    Last Update Posted:
    Jan 23, 2019
    Last Verified:
    Aug 1, 2018
    Keywords provided by Eli Lilly and Company
    Postmenopausal females
    Volunteers

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL Placebo
    Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL Single dose of placebo administered IV or SC
    Period Title: Overall Study
    STARTED 6 6 6 6 6 6 6 6 12
    RECEIVED STUDY DRUG 6 6 6 6 6 6 6 6 12
    COMPLETED 6 6 6 5 6 6 6 6 12
    NOT COMPLETED 0 0 0 1 0 0 0 0 0

    Baseline Characteristics

    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL Placebo Total
    Arm/Group Description Participants received 7.5 mg LY2541546 IV Participants received25 mg LY2541546 IV Participants received 75 mg LY2541546 IV Participants received225 mg LY541546 IV Participants received750 mg LY2541546 IV Participants received 150 mg LY2541546 subcutaneously (SC) Participants received 225 mg LY2541546 IV. Open label(OL) Participants received 750 mg LY2541546 IV, OL Participants single dose of placebo administered IV or SC Total of all reporting groups
    Overall Participants 6 6 6 6 6 6 6 6 12 60
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.0
    (3.7)
    56.3
    (4.6)
    60.0
    (5.3)
    53.6
    (4.6)
    59.0
    (5.7)
    58.5
    (4.5)
    59.7
    (6.7)
    64.2
    (5.9)
    57.1
    (5.2)
    57.9
    (5.8)
    Sex: Female, Male (Count of Participants)
    Female
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    12
    100%
    60
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    Caucasian
    5
    83.3%
    5
    83.3%
    6
    100%
    5
    83.3%
    5
    83.3%
    6
    100%
    6
    100%
    6
    100%
    11
    91.7%
    55
    91.7%
    African
    1
    16.7%
    1
    16.7%
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    3
    5%
    Native American
    0
    0%
    0
    0%
    0
    0%
    1
    16.7%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    1.7%
    West Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    8.3%
    1
    1.7%
    Region of Enrollment (Count of Participants)
    United States
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    12
    100%
    60
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
    Description An SAE is any AE from this study that results in one of the following outcomes: death initial or prolonged inpatient hospitalization a life-threatening experience (that is, immediate risk of dying) persistent or significant disability/incapacity congenital anomaly/birth defect or is considered significant by the investigator for any other reason.
    Time Frame Day 1 through Day 85

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug.
    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of placebo administered IV or SC Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL
    Measure Participants 6 6 6 6 6 6 12 6 6
    Number [participants]
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Secondary Outcome
    Title Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Time Zero to Infinity (AUC0-∞) of LY2541546
    Description
    Time Frame Day 1: Predose,30 minutes,45 mintues,1 hour (hr), 1.5 hr, 3 hr, 6 hr, 12 hr Postdose; Day (D) 3,D5 ,D8, D11, D15, D29, D43, D57, D71,D85: anytime

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had sufficient evaluable results for PK analysis.
    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL
    Measure Participants 6 6 5 6 6 6 6 6
    Geometric Mean (Geometric Coefficient of Variation) [picomol*hr/mL]
    411
    (51)
    2540
    (22)
    16400
    (16)
    86600
    (14)
    390000
    (14)
    9150
    (40)
    94500
    (10)
    507000
    (14)
    3. Secondary Outcome
    Title Pharmacodynamics (PD): Change From Baseline in Lumbar Spine Bone Mineral Density (BMD)
    Description A BMD test measures the amount of mineral (such as calcium) in a defined area of bone in grams per square centimeter (g/cm²) and is calculate by dexascan.
    Time Frame Baseline (predose), Day 29 anytime, Day 85 anytime

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had evaluable results at the analyzed time points.
    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of placebo administered IV or SC Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL
    Measure Participants 6 6 6 6 6 6 12 6 6
    Day 29
    0.01
    -0.01
    0.01
    0.01
    0.00
    0.00
    -0.00
    0.01
    -0.00
    Day 85
    -0.00
    -0.01
    0.01
    0.02
    0.03
    0.01
    -0.00
    0.01
    0.02
    4. Secondary Outcome
    Title Pharmacodynamics (PD): Percent Change From Baseline in N-terminal Propeptide of Procollagen Type 1 (P1NP)
    Description N-terminal propeptide of procollagen type 1 (P1NP) is a main bone formation marker. An increase of P1NP in serum reflects elevated anabolic activities of the bone. Percentage change in P1NP from baseline to post baseline time points was analyzed using the repeated-measures model.
    Time Frame Baseline (predose), Day 29 anytime, Day 85 anytime

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had evaluable results at the analyzed timepoints.
    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of placebo administered IV or SC Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL
    Measure Participants 6 6 6 6 6 6 12 6 6
    Day 29
    9.36
    44.00
    24.86
    47.54
    224.16
    31.42
    6.18
    106.76
    334.52
    Day 85
    9.28
    25.77
    14.27
    24.07
    33.84
    19.24
    9.86
    33.59
    23.98
    5. Secondary Outcome
    Title Immunogenicity: The Number of Participants With Anti-LY2541546 Antibodies
    Description A validated assay designed to perform in the presence of LY2541546 was used for to assess development of antibodies.
    Time Frame Day 1: Predose, Day 29 anytime, Day 85 anytime

    Outcome Measure Data

    Analysis Population Description
    All participants who received study drug and had evaluable results at the analyzed time points.
    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of placebo administered IV or SC Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL
    Measure Participants 6 6 6 6 6 6 12 6 6
    Day 1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 29
    0
    0%
    0
    0%
    0
    0%
    2
    33.3%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Day 85
    0
    0%
    0
    0%
    1
    16.7%
    4
    66.7%
    1
    16.7%
    2
    33.3%
    0
    0%
    0
    0%
    2
    16.7%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title 7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Arm/Group Description Single dose of 7.5 mg LY2541546 administered intravenously (IV) Single dose of 25 mg LY2541546 administered IV Single dose of 75 mg LY2541546 administered IV Single dose of 225 mg LY2541546 administered IV Single dose of 750 mg LY2541546 administered IV Single dose of 150 mg LY2541546 administered subcutaneous (SC) Single dose of placebo administered IV or SC Single dose of 225 mg LY2541546 administered IV, open label (OL) Single dose of 750 mg LY2541546 administered IV, OL
    All Cause Mortality
    7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/12 (0%) 0/6 (0%) 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    7.5 mg LY2541546 - IV 25 mg LY2541546 - IV 75 mg LY2541546 - IV 225 mg LY2541546 - IV 750 mg LY2541546 - IV 150 mg LY2541546 - SC Placebo 225 mg LY2541546 - IV, OL 750 mg LY2541546 - IV, OL
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 5/6 (83.3%) 6/6 (100%) 4/6 (66.7%) 4/6 (66.7%) 4/6 (66.7%) 5/6 (83.3%) 7/12 (58.3%) 6/6 (100%) 5/6 (83.3%)
    Cardiac disorders
    Conduction disorder 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Ventricular tachycardia 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Vertigo 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Eye disorders
    Conjunctivitis 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Conjunctivitis allergic 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Eye pain 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Lacrimation increased 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Visual disturbance 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Gastrointestinal disorders
    Abdominal pain 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Aphthous stomatitis 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Dental caries 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Diarrhoea 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Dyspepsia 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Flatulence 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nausea 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 2/6 (33.3%) 2 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Stomach discomfort 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Toothache 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Vomiting 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 3 0/6 (0%) 0
    General disorders
    Application site irritation 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Catheter site erythema 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Catheter site pain 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Fatigue 3/6 (50%) 3 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nodule 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pyrexia 0/6 (0%) 0 1/6 (16.7%) 2 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Vessel puncture site haematoma 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Infections and infestations
    Gastroenteritis viral 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Herpes simplex 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Myringitis 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Otitis media 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Upper respiratory tract infection 1/6 (16.7%) 1 3/6 (50%) 5 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Viral infection 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Viral upper respiratory tract infection 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 3/6 (50%) 4 1/6 (16.7%) 1 1/6 (16.7%) 1 1/12 (8.3%) 1 0/6 (0%) 0 2/6 (33.3%) 2
    Injury, poisoning and procedural complications
    Arthropod bite 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Contusion 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Fall 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Joint sprain 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Thermal burn 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Metabolism and nutrition disorders
    Anorexia 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1
    Back pain 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 2/12 (16.7%) 2 1/6 (16.7%) 1 1/6 (16.7%) 1
    Joint swelling 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Muscle spasms 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Myalgia 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Neck pain 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Nervous system disorders
    Dizziness 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 1/12 (8.3%) 1 1/6 (16.7%) 1 0/6 (0%) 0
    Headache 2/6 (33.3%) 3 3/6 (50%) 4 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 1/12 (8.3%) 1 3/6 (50%) 3 1/6 (16.7%) 1
    Hypoaesthesia 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1
    Syncope vasovagal 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Psychiatric disorders
    Insomnia 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Stress 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Renal and urinary disorders
    Polyuria 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Urinary incontinence 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Pharyngolaryngeal pain 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Productive cough 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Respiratory tract congestion 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Sinus congestion 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Skin and subcutaneous tissue disorders
    Acne 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/12 (8.3%) 1 0/6 (0%) 0 0/6 (0%) 0
    Alopecia 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Dermatitis 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0
    Dermatitis contact 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 2/12 (16.7%) 2 1/6 (16.7%) 1 1/6 (16.7%) 1
    Vascular disorders
    Hot flush 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/12 (0%) 0 0/6 (0%) 0 0/6 (0%) 0
    Hypertension 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/12 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0

    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
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT01742078
    Other Study ID Numbers:
    • 11952
    • I2M-MC-GSDA
    First Posted:
    Dec 5, 2012
    Last Update Posted:
    Jan 23, 2019
    Last Verified:
    Aug 1, 2018