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A Study of LY3009104(Baricitinib) for Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01247350
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Healthy Volunteer
Interventions Drug: LY3009104
Drug: Placebo
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2 mg LY3009104 (Baricitinib) 5 mg LY3009104 10 mg LY3009104 14 mg LY3009104 Placebo
Hide Arm/Group Description 2 mg administered orally once on Day 1 (single dose) 5 mg administered orally once on Day 1 (single dose) 10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose) 14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose) administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose)
Period Title: Overall Study
Started 6 6 6 7 9
Received Multiple Doses of Study Drug 0 0 6 6 5
Completed 6 6 5 6 8
Not Completed 0 0 1 1 1
Reason Not Completed
Adverse Event             0             0             1             0             0
Withdrawal by Subject             0             0             0             1             0
Entry criteria not met             0             0             0             0             1
Arm/Group Title 2 mg LY3009104 5 mg LY3009104 10 mg LY3009104 14 mg LY3009104 Placebo Total
Hide Arm/Group Description 2 mg administered orally once on Day 1 (single dose) 5 mg administered orally once on Day 1 (single dose) 10 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days ((multiple dose) 14 mg administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose) administered orally on Day 1 (single dose) and following a 7-day washout period, administered once daily for 10 days (multiple dose) Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 7 9 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 7 participants 9 participants 34 participants
46.3  (10.8) 48.0  (15.0) 46.7  (9.0) 51.1  (6.3) 45.1  (10.7) 47.4  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 9 participants 34 participants
Female 3 2 3 2 2 12
Male 3 4 3 5 7 22
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 6 participants 6 participants 6 participants 7 participants 9 participants 34 participants
6 6 6 7 9 34
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 7 participants 9 participants 34 participants
6 6 6 7 9 34
1.Primary Outcome
Title Number of Participants With Clinically Significant Effects
Hide Description Adverse events were considered clinically significant effects. A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.
Time Frame Days 1-10 for Cohorts 1 & 2, Days 1-7 for single dose of Cohorts 3 & 4, Days 8-31 for multiple doses
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug.
Arm/Group Title 2 mg LY3009104 Single Dose 5 mg LY3009104 Single Dose 10 mg LY3009104 Single Dose 14 mg LY3009104 Single Dose Placebo Single Dose 10 mg LY3009104 Multiple Dose 14 mg LY3009104 Multiple Dose Placebo Multiple Dose
Hide Arm/Group Description:
2 mg administered orally once on Day 1
5 mg administered orally once on Day 1
10 mg administered orally once on Day 1
14 mg administered orally once on Day 1
administered orally once on Day 1
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
Overall Number of Participants Analyzed 6 6 6 7 9 6 6 5
Measure Type: Count of Participants
Unit of Measure: Participants
Serious Adverse Events 0 0 0 0 0 0 0 0
Nonserious Adverse Events 1 1 2 7 6 5 4 2
2.Secondary Outcome
Title Pharmacokinetics: Maximum Concentration (Cmax) of LY3009104
Hide Description Cmax of Day 1 is Cmax after single dose, and Cmax of Day 17 is Cmax at steady-state.
Time Frame Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Arm/Group Title 2 mg LY3009104 Day 1 5 mg LY3009104 Day 1 10 mg LY3009104 Day 1 14 mg LY3009104 Day 1 10 mg LY3009104 Day 17 14 mg LY3009104 Day 17
Hide Arm/Group Description:
2 mg administered orally once on Day 1
5 mg administered orally once on Day 1
10 mg administered orally once on Day 1
14 mg administered orally once on Day 1
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
Overall Number of Participants Analyzed 6 6 6 7 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomoles/Liter (nmol/L)
76.1
(29%)
220
(35%)
327
(43%)
410
(19%)
319
(30%)
439
(9%)
3.Secondary Outcome
Title Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3009104
Hide Description AUC is the measure of total plasma exposure of a drug over a given time period. AUC of Day 1 is AUC from 0 to 24 hours. AUC of Day 17 is AUC during one dosing interval at steady-state.
Time Frame Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Arm/Group Title 2 mg LY3009104 Day 1 5 mg LY3009104 Day 1 10 mg LY3009104 Day 1 14 mg LY3009104 Day 1 10 mg LY3009104 Day 17 14 mg LY3009104 Day 17
Hide Arm/Group Description:
2 mg administered orally once on Day 1
5 mg administered orally once on Day 1
10 mg administered orally once on Day 1
14 mg administered orally once on Day 1
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
Overall Number of Participants Analyzed 6 6 6 7 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanomoles*hour/Liter (nmol*h/L)
403
(10%)
1240
(23%)
1730
(21%)
2790
(14%)
1970
(18%)
3060
(17%)
4.Secondary Outcome
Title Pharmacokinetics: Half-Life(t1/2) of LY3009104
Hide Description Half life (t1/2) is the time measured for the plasma concentration of LY3009104 to decrease by one half.
Time Frame Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Arm/Group Title 2 mg LY3009104 Day 1 5 mg LY3009104 Day 1 10 mg LY3009104 Day 1 14 mg LY3009104 Day 1 10 mg LY3009104 Day 17 14 mg LY3009104 Day 17
Hide Arm/Group Description:
2 mg administered orally once on Day 1
5 mg administered orally once on Day 1
10 mg administered orally once on Day 1
14 mg administered orally once on Day 1
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
Overall Number of Participants Analyzed 6 6 6 7 5 6
Geometric Mean (Full Range)
Unit of Measure: hour (h)
5.19
(3.88 to 6.31)
6.82
(5.70 to 7.79)
6.43
(4.37 to 9.90)
8.48
(6.95 to 10.8)
8.57
(7.43 to 9.30)
9.41
(7.24 to 13.1)
5.Secondary Outcome
Title Pharmacokinetics: Apparent Volume of Distribution of LY3009104
Hide Description Apparent volume of distribution is used to quantify the distribution of a drug between plasma and the rest of the body after dosing. It is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Day 1, it is apparent volume of distribution during the terminal phase after single dose. Day 17, it is apparent volume of distribution during the terminal phase at steady-state.
Time Frame Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Arm/Group Title 2 mg LY3009104 Day 1 5 mg LY3009104 Day 1 10 mg LY3009104 Day 1 14 mg LY3009104 Day 1 10 mg LY3009104 Day 17 14 mg LY3009104 Day 17
Hide Arm/Group Description:
2 mg administered orally once on Day 1
5 mg administered orally once on Day 1
10 mg administered orally once on Day 1
14 mg administered orally once on Day 1
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
Overall Number of Participants Analyzed 6 6 6 7 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter (L)
96.3
(18%)
99.4
(29%)
138
(41%)
150
(19%)
169
(24%)
167
(23%)
6.Secondary Outcome
Title Pharmacokinetics: Apparent Total Body Clearance of LY3009104
Hide Description Apparent total body clearance is the volume of plasma from which the drug is completely removed in a given time period. For Day 1, it is apparent total body clearance of drug after single dose. For Day 17, it is apparent total body clearance of drug at steady-state.
Time Frame Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Arm/Group Title 2 mg LY3009104 Day 1 5 mg LY3009104 Day 1 10 mg LY3009104 Day 1 14 mg LY3009104 Day 1 10 mg LY3009104 Day 17 14 mg LY3009104 Day 17
Hide Arm/Group Description:
2 mg administered orally once on Day 1
5 mg administered orally once on Day 1
10 mg administered orally once on Day 1
14 mg administered orally once on Day 1
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
Overall Number of Participants Analyzed 6 6 6 7 5 6
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter/hour (L/h)
12.9
(11%)
10.1
(22%)
14.8
(20%)
12.2
(17%)
13.7
(18%)
12.3
(17%)
7.Secondary Outcome
Title Pharmacokinetics: Time of Maximum Observed LY3009104 Concentration (Tmax)
Hide Description Tmax is time to reach maximum observed drug concentration. For Day 1, it is tmax after single dose. For Day 17, it is tmax at steady-state.
Time Frame Day 1 and Day 17: predose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 38 and 48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug and had pharmacokinetics (PK) samples for the analyses.
Arm/Group Title 2 mg LY3009104 Day 1 5 mg LY3009104 Day 1 10 mg LY3009104 Day 1 14 mg LY3009104 Day 1 10 mg LY3009104 Day 17 14 mg LY3009104 Day 17
Hide Arm/Group Description:
2 mg administered orally once on Day 1
5 mg administered orally once on Day 1
10 mg administered orally once on Day 1
14 mg administered orally once on Day 1
Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days
Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days
Overall Number of Participants Analyzed 6 6 6 7 5 6
Median (Full Range)
Unit of Measure: hour (h)
1.00
(0.50 to 2.00)
1.00
(0.50 to 1.00)
1.25
(0.50 to 2.00)
1.00
(0.50 to 2.10)
1.00
(0.50 to 2.00)
1.00
(1.00 to 1.00)
8.Secondary Outcome
Title Pharmacokinetics: Renal Excretion of LY3009104
Hide Description Percentage of LY3009104 excreted in urine from zero to 24 hours.
Time Frame Day 1: continuous for 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were administered study drug (10 mg and 14 mg LY3009104 per protocol) and had pharmacokinetics (PK) samples for the analyses.
Arm/Group Title 10 mg LY3009104 Day 1 14 mg LY3009104 Day 1
Hide Arm/Group Description:
10 mg administered orally on Day 1
14 mg administered orally on Day 1
Overall Number of Participants Analyzed 6 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percentage of drug
75.8
(7%)
63.6
(13%)
Time Frame From starting of the dose to follow-up. Adverse events (AE) for single dose were observed from Day 1 to Day 10±2 days (Cohorts 1&2) or Day 7 (Cohorts 3&4). AE for multiple doses were observed from Day 8 to Day 31±3 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2 mg LY3009104 - Single Dose 5 mg LY3009104 - Single Dose 10 mg LY3009104 - Single Dose 14 mg LY3009104 - Single Dose Placebo - Single Dose 10 mg LY3009104 - Multiple Dose 14 mg LY3009104 - Multiple Dose Placebo - Multiple Dose
Hide Arm/Group Description 2 mg administered orally once on Day 1 5 mg administered orally once on Day 1 10 mg administered orally on Day 1 14 mg administered orally on Day 1 administered orally on Day 1 Following a 7-day washout period, participants in the 10 mg LY3009104 single-dose group received 10 mg LY3009104 once daily for 10 days Following a 7-day washout period, participants in the 14 mg LY3009104 single-dose group received 14 mg LY3009104 once daily for 10 days Following a 7-day washout period, participants in the placebo single-dose group received placebo once daily for 10 days.
All-Cause Mortality
2 mg LY3009104 - Single Dose 5 mg LY3009104 - Single Dose 10 mg LY3009104 - Single Dose 14 mg LY3009104 - Single Dose Placebo - Single Dose 10 mg LY3009104 - Multiple Dose 14 mg LY3009104 - Multiple Dose Placebo - Multiple Dose
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
2 mg LY3009104 - Single Dose 5 mg LY3009104 - Single Dose 10 mg LY3009104 - Single Dose 14 mg LY3009104 - Single Dose Placebo - Single Dose 10 mg LY3009104 - Multiple Dose 14 mg LY3009104 - Multiple Dose Placebo - Multiple Dose
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 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/7 (0.00%)      0/9 (0.00%)      0/6 (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%
2 mg LY3009104 - Single Dose 5 mg LY3009104 - Single Dose 10 mg LY3009104 - Single Dose 14 mg LY3009104 - Single Dose Placebo - Single Dose 10 mg LY3009104 - Multiple Dose 14 mg LY3009104 - Multiple Dose Placebo - Multiple Dose
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   1/6 (16.67%)      1/6 (16.67%)      2/6 (33.33%)      7/7 (100.00%)      6/9 (66.67%)      5/6 (83.33%)      4/6 (66.67%)      2/5 (40.00%)    
Blood and lymphatic system disorders                 
Lymphadenopathy † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Thrombocytosis † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Gastrointestinal disorders                 
Abdominal Discomfort † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Constipation † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 1/5 (20.00%)  1
Diarrhoea † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/5 (0.00%)  0
Nausea † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
General disorders                 
Application Site Reaction † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Chest Discomfort † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Discomfort † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Fatigue † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/5 (0.00%)  0
Vessel Puncture Site Haematoma † 1  1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 3/7 (42.86%)  6 1/9 (11.11%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations                 
Oral Herpes † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Injury, poisoning and procedural complications                 
Excoriation † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  4 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Skin Laceration † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
Investigations                 
Neutrophil Count Decreased † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 5/7 (71.43%)  6 0/9 (0.00%)  0 1/6 (16.67%)  1 3/6 (50.00%)  3 0/5 (0.00%)  0
Reticulocyte Count Decreased † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Back Pain † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/6 (16.67%)  2 0/6 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders                 
Dizziness Postural † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Headache † 1  1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 3/9 (33.33%)  3 2/6 (33.33%)  2 1/6 (16.67%)  1 0/5 (0.00%)  0
Presyncope † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Cough † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/5 (20.00%)  1
Nasal Congestion † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 1/5 (20.00%)  1
Rhinorrhoea † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/5 (0.00%)  0
Throat Irritation † 1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/5 (20.00%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
[Not Specified]
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: NCT01247350     History of Changes
Other Study ID Numbers: 14089
I4V-JE-JADM ( Other Identifier: Eli Lilly and Company )
First Submitted: November 17, 2010
First Posted: November 24, 2010
Results First Submitted: March 10, 2017
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018