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A Study of LY2624803 in Japanese Participants With Transient Insomnia

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ClinicalTrials.gov Identifier: NCT01784614
Recruitment Status : Completed
First Posted : February 6, 2013
Results First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator)
Condition Sleep Initiation and Maintenance Disorders
Interventions Drug: LY2624803 - Solution
Drug: LY2624803 - Capsule
Drug: Placebo - Solution
Drug: Placebo - Capsule
Enrollment 24
Recruitment Details  
Pre-assignment Details This was a double-blind, randomized, placebo-controlled, 4-period cross-over study. The first 3 of which were used for polysomnography (PSG) measurements, and the fourth period was used to determine plasma concentrations of LY2624803 to estimate pharmacokinetic (PK) parameters.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8
Hide Arm/Group Description

Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.

Period 2: Single dose of one 1.0 milligram (mg) LY2624803 capsule plus placebo solution administered orally.

Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

There was at least 7 days washout between each period.

Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.

Period 3: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.

There was at least 7 days washout between each period.

Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 2: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.

Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.

There was at least 7 days washout between each period.

Period 1: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 4: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.

There was at least 7 days washout between each period.

Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.

Period 2: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

There was at least 7 days washout between each period.

Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.

Period 3: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.

Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.

There was at least 7 days washout between each period.

Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 2: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.

Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.

Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.

There was at least 7 days washout between each period.

Period 1: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.

Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.

Period 4: Single dose of 1.0 mg LY2624803 solution plus 1 placebo capsule administered orally.

There was at least 7 days washout between each period.

Period Title: Period 1
Started 3 3 3 3 3 3 3 3
Received at Least 1 Dose of Study Drug 3 3 3 3 3 3 3 3
Completed 3 3 3 3 3 3 3 3 [1]
Not Completed 0 0 0 0 0 0 0 0
[1]
One participant withdrew consent after completed Period 1 and did not enter Period 2.
Period Title: Period 2
Started 3 3 3 3 3 3 3 2
Completed 3 3 [1] 3 3 3 3 3 2
Not Completed 0 0 0 0 0 0 0 0
[1]
One participant withdrew consent after completed Period 2 and did not enter Period 3.
Period Title: Period 3
Started 3 2 3 3 3 3 3 2
Completed 3 2 3 3 3 3 3 2
Not Completed 0 0 0 0 0 0 0 0
Period Title: Period 4
Started 3 2 3 3 3 3 3 2
Completed 3 2 3 3 3 3 3 2
Not Completed 0 0 0 0 0 0 0 0
Arm/Group Title Overall
Hide Arm/Group Description

Single dose of 0.1 mg LY2624803 oral solution plus 1 placebo capsule, one 1.0, 3.0 or 6.0 mg LY2624803 capsule plus placebo solution administered orally in up to 2 of 4 periods or 1 placebo capsule plus placebo solution administered orally in up to 1 of 4 periods.

There was at least 7 days washout between each period.

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
54.1  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
14
  58.3%
Male
10
  41.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
24
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 24 participants
24
1.Primary Outcome
Title Wake After Sleep Onset (WASO) With LY2624803 Compared to Placebo
Hide Description WASO was calculated as total time in awake epochs between sleep onset time (first stage 2 epoch) and the end of the primary recording period (8 hours after lights -off). Data presented are Geometric Least Squares (LS) means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.
Time Frame 8 hours in Periods 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.
Arm/Group Title 0.1 mg LY2624803 1.0 mg LY2624803 3.0 mg LY2624803 6.0 mg LY2624803 Placebo
Hide Arm/Group Description:
Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Overall Number of Participants Analyzed 8 17 16 8 17
Geometric Mean (90% Confidence Interval)
Unit of Measure: minutes (min)
58.88
(33.32 to 104.05)
40.70
(25.67 to 64.54)
32.27
(20.27 to 51.37)
18.42
(10.44 to 32.51)
61.10
(38.60 to 96.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.1 mg LY2624803, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.908
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS mean
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.56 to 1.65
Estimation Comments Ratio of Geometric LS mean is WASO of 0.1 mg LY2624803 / Placebo.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 1.0 mg LY2624803, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS mean
Estimated Value 0.67
Confidence Interval (2-Sided) 90%
0.45 to 0.98
Estimation Comments Ratio of Geometric LS mean is WASO of 1.0 mg LY2624803 / Placebo.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3.0 mg LY2624803, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS mean
Estimated Value 0.53
Confidence Interval (2-Sided) 90%
0.36 to 0.78
Estimation Comments Ratio of Geometric LS mean is WASO of 3.0 mg LY2624803 / Placebo.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 6.0 mg LY2624803, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS mean
Estimated Value 0.30
Confidence Interval (2-Sided) 90%
0.18 to 0.51
Estimation Comments Ratio of Geometric LS mean is WASO of 6.0 mg LY2624803 / Placebo.
2.Secondary Outcome
Title Latency to Persistent Sleep (LPS)
Hide Description LPS is defined as the latency from the lights-off time to the first stage 2 sleep followed by at least 10 consecutive minutes of sleep epochs. Data presented are Geometric LS means. Geometric LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.
Time Frame 8 hours in Periods 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.
Arm/Group Title 0.1 mg LY2624803 1.0 mg LY2624803 3.0 mg LY2624803 6.0 mg LY2624803 Placebo
Hide Arm/Group Description:
Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Overall Number of Participants Analyzed 8 17 16 8 17
Geometric Mean (90% Confidence Interval)
Unit of Measure: min
14.30
(7.41 to 27.59)
8.39
(5.41 to 13.02)
7.84
(5.01 to 12.28)
7.27
(3.78 to 13.99)
10.40
(6.72 to 16.09)
3.Secondary Outcome
Title Total Sleep Time (TST)
Hide Description TST is defined as the total time in sleep epochs from sleep onset time to the end of the primary recording period (8 hours after lights -off). LS mean was calculated using mixed models analysis. The model included factors for treatment, treatment sequence, period and participants.
Time Frame 8 hours in Periods 1, 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had PSG measurements in Periods 1, 2 and 3.
Arm/Group Title 0.1 mg LY2624803 1.0 mg LY2624803 3.0 mg LY2624803 6.0 mg LY2624803 Placebo
Hide Arm/Group Description:
Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
Overall Number of Participants Analyzed 8 17 16 8 17
Least Squares Mean (90% Confidence Interval)
Unit of Measure: min
374.37
(333.21 to 415.53)
404.35
(373.53 to 435.17)
420.65
(389.43 to 451.88)
452.09
(411.06 to 493.12)
373.78
(343.12 to 404.44)
4.Secondary Outcome
Title PK: Maximum Plasma Concentration (Cmax) of LY2624803 After Single Oral Dose in Period 4
Hide Description [Not Specified]
Time Frame Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.
Arm/Group Title 0.1 mg LY2624803 1.0 mg LY2624803 3.0 mg LY2624803 6.0 mg LY2624803
Hide Arm/Group Description:
Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
Overall Number of Participants Analyzed 6 5 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
4.88
(10%)
43.8
(10%)
146
(13%)
251
(9%)
5.Secondary Outcome
Title PK: Area Under the Concentration-Time Curve From Time 0 to Infinity [AUC(0-∞)] of LY2624803 After Single Oral Dose in Period 4
Hide Description [Not Specified]
Time Frame Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 10, 12, 18, and 42 hours post-dose in Period 4
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received a single oral dose of LY2624803 in Period 4 and had evaluable PK data.
Arm/Group Title 0.1 mg LY2624803 1.0 mg LY2624803 3.0 mg LY2624803 6.0 mg LY2624803
Hide Arm/Group Description:
Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
Overall Number of Participants Analyzed 6 5 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms•hour/milliliter (ng•hr/mL)
79.0
(39%)
714
(20%)
2240
(34%)
4220
(24%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.1 mg LY2624803 - Periods 1-3 1.0 mg LY2624803 - Periods 1-3 3.0 mg LY2624803 - Periods 1-3 6.0 mg LY2624803 - Periods 1-3 Placebo - Periods 1-3 0.1 mg LY2624803 - Period 4 1.0 mg LY2624803 - Period 4 3.0 mg LY2624803 - Period 4 6 mg LY2624803 - Period 4
Hide Arm/Group Description Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3. Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3. Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3. Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4. Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4. Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4. Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
All-Cause Mortality
0.1 mg LY2624803 - Periods 1-3 1.0 mg LY2624803 - Periods 1-3 3.0 mg LY2624803 - Periods 1-3 6.0 mg LY2624803 - Periods 1-3 Placebo - Periods 1-3 0.1 mg LY2624803 - Period 4 1.0 mg LY2624803 - Period 4 3.0 mg LY2624803 - Period 4 6 mg LY2624803 - Period 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.1 mg LY2624803 - Periods 1-3 1.0 mg LY2624803 - Periods 1-3 3.0 mg LY2624803 - Periods 1-3 6.0 mg LY2624803 - Periods 1-3 Placebo - Periods 1-3 0.1 mg LY2624803 - Period 4 1.0 mg LY2624803 - Period 4 3.0 mg LY2624803 - Period 4 6 mg LY2624803 - Period 4
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   0/9 (0.00%)      0/17 (0.00%)      0/17 (0.00%)      0/8 (0.00%)      0/18 (0.00%)      0/6 (0.00%)      0/5 (0.00%)      0/6 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.1 mg LY2624803 - Periods 1-3 1.0 mg LY2624803 - Periods 1-3 3.0 mg LY2624803 - Periods 1-3 6.0 mg LY2624803 - Periods 1-3 Placebo - Periods 1-3 0.1 mg LY2624803 - Period 4 1.0 mg LY2624803 - Period 4 3.0 mg LY2624803 - Period 4 6 mg LY2624803 - Period 4
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   2/9 (22.22%)      3/17 (17.65%)      3/17 (17.65%)      0/8 (0.00%)      3/18 (16.67%)      0/6 (0.00%)      2/5 (40.00%)      1/6 (16.67%)      3/5 (60.00%)    
Eye disorders                   
Conjunctivitis  1  0/9 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders                   
Diarrhoea  1  0/9 (0.00%)  0 1/17 (5.88%)  1 1/17 (5.88%)  1 0/8 (0.00%)  0 1/18 (5.56%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
General disorders                   
Feeling abnormal  1  1/9 (11.11%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Vessel puncture site pain  1  0/9 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 1/5 (20.00%)  1
Injury, poisoning and procedural complications                   
Contusion  1  0/9 (0.00%)  0 0/17 (0.00%)  0 1/17 (5.88%)  1 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Muscle strain  1  1/9 (11.11%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
Back pain  1  0/9 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders                   
Dizziness  1  0/9 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
Headache  1  0/9 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Poor quality sleep  1  0/9 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/8 (0.00%)  0 2/18 (11.11%)  3 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Somnolence  1  0/9 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 1/18 (5.56%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
Cough  1  1/9 (11.11%)  1 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Upper airway obstruction  1  0/9 (0.00%)  0 1/17 (5.88%)  1 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders                   
Dermatitis contact  1  0/9 (0.00%)  0 0/17 (0.00%)  0 0/17 (0.00%)  0 0/8 (0.00%)  0 0/18 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1 1/6 (16.67%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01784614     History of Changes
Other Study ID Numbers: 12662
I2K-JE-ZZAW ( Other Identifier: Eli Lilly and Company )
First Submitted: February 4, 2013
First Posted: February 6, 2013
Results First Submitted: December 22, 2015
Results First Posted: January 28, 2016
Last Update Posted: January 28, 2016