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Trial record 5 of 27 for:    Edivoxetine OR LY2216684

A Study to Measure if There is Any Difference in How the Body Breaks Down or Inactivates Either Fluoxetine or LY2216684 When Both of These Medicines Are Given Together.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01243957
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : October 22, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: LY2216684
Drug: Fluoxetine
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
38.3  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
4
  20.0%
Male
16
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
2
  10.0%
Not Hispanic or Latino
18
  90.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  25.0%
White
15
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of LY2216684
Hide Description The Least Squares (LS) geometric mean AUCτ of LY2216684 was calculated based on the LY2216684 plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.
Time Frame Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description:

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Overall Number of Participants Analyzed 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
LY2216684 alone
677
(609 to 753)
LY2216684 + fluoxetine
1210
(1090 to 1350)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.79
Confidence Interval (2-Sided) 90%
1.61 to 2.00
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of LY2216684
Hide Description The Least Squares (LS) geometric mean Cmax of LY2216684 was determined when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The Day 27-to-Day 3 ratio of the LY2216684 LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated.
Time Frame Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description:

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Overall Number of Participants Analyzed 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram per milliliter (ng/mL)
LY2216684 alone
55.5
(50.8 to 60.7)
LY2216684 + fluoxetine
90.6
(82.8 to 99.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.63
Confidence Interval (2-Sided) 90%
1.49 to 1.79
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Hide Description Tmax of LY2216684 was determined using the median of paired differences between the 2 treatment groups when LY2216684 was administered alone (Day 3) and when LY2216684 was coadministered with fluoxetine (Day 27). The 90% confidence interval (CI) for the median of differences was calculated.
Time Frame Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 3 and 27
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description:

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Overall Number of Participants Analyzed 20
Median (90% Confidence Interval)
Unit of Measure: hours
LY2216684 alone
3.00
(1.00 to 6.00)
LY2216684 + fluoxetine
3.00
(2.00 to 4.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5459
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.50 to 0.50
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time-Curve Over a 24-Hour Dosing Interval (AUCτ) of Fluoxetine and Norfluoxetine
Hide Description The Least Squares (LS) geometric means AUCτ of fluoxetine and norfluoxetine were calculated based on the fluoxetine and norfluoxetine plasma concentration time curves from time 0 hour (hr) to time 24 hr (tau [τ]) when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY22166684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of AUCτ and the associated 90% confidence interval (CI) of the ratios were calculated.
Time Frame Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description:

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Overall Number of Participants Analyzed 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
fluoxetine alone
3450
(3060 to 3890)
fluoxetine + LY2216684
3500
(3100 to 3940)
norfluoxetine alone
3170
(2790 to 3590)
norfluoxetine + LY2216684
3280
(2890 to 3720)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments Ratio of Geometric LS Means of AUCτ for fluoxetine alone and fluoxetine + LY2216684.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.99 to 1.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments Ratio of Geometric LS Means of AUCτ for norfluoxetine alone and norfluoxetine + LY2216684.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.04
Confidence Interval (2-Sided) 90%
1.01 to 1.06
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Fluoxetine and Norfluoxetine
Hide Description The Least Squares (LS) geometric means Cmax of fluoxetine and norfluoxetine were determined when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The Day 27-to-Day 24 ratios of fluoxetine and norfluoxetine LS geometric means of Cmax and the associated 90% confidence interval (CI) of the ratios were calculated.
Time Frame Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description:

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Overall Number of Participants Analyzed 20
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram per milliliter (ng/mL)
fluoxetine alone
160
(142 to 180)
fluoxetine + LY2216684
160
(142 to 180)
norfluoxetine alone
144
(127 to 163)
norfluoxetine + LY2216684
148
(131 to 168)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments Ratio of Geometric LS Means of Cmax for fluoxetine alone and fluoxetine + LY2216684
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
0.97 to 1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments Ratio of Geometric LS Means of Cmax for norfluoxetine alone and norfluoxetine + LY2216684.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Geometric LS Means
Estimated Value 1.03
Confidence Interval (2-Sided) 90%
1.00 to 1.07
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Fluoxetine and Norfluoxetine
Hide Description Tmax of fluoxetine and norfluoxetine was determined using the median of paired differences between the 2 treatment groups when fluoxetine was administered alone (Day 24) and when fluoxetine was coadministered with LY2216684 (Day 27). The 90% confidence interval (CI) for the median of differences was calculated.
Time Frame Predose and 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose on Days 24 and 27
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included participants who were randomized, received study drug, and had at least 1 postdose safety assessment.
Arm/Group Title LY2216684 + Fluoxetine
Hide Arm/Group Description:

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

Overall Number of Participants Analyzed 20
Median (90% Confidence Interval)
Unit of Measure: hours
fluoxetine alone
6.00
(3.00 to 12.05)
fluoxetine + LY2216684
6.00
(0.00 to 12.00)
norfluoxetine alone
12.00
(0.00 to 24.00)
norfluoxetine + LY2216684
4.00
(0.00 to 12.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments Ratio of Geometric LS Means of Tmax for fluoxetine alone and fluoxetine + LY2216684.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4230
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.08
Confidence Interval (2-Sided) 90%
-3.00 to 1.42
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LY2216684 + Fluoxetine
Comments Ratio of Geometric LS Means of Tmax for norfluoxetine alone and norfluoxetine + LY2216684.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0293
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -4.00
Confidence Interval (2-Sided) 90%
-6.50 to -1.00
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2216684 Fluoxetine LY2216684 + Fluoxetine
Hide Arm/Group Description LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27. Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

LY2216684: 18 milligrams (mg) oral (po) once daily (QD) on Days 1-3 and Days 25-27.

Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27).

All-Cause Mortality
LY2216684 Fluoxetine LY2216684 + Fluoxetine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 Fluoxetine LY2216684 + Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2216684 Fluoxetine LY2216684 + Fluoxetine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/20 (80.00%)      13/20 (65.00%)      14/20 (70.00%)    
Cardiac disorders       
Palpitations  1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Tachycardia  1  2/20 (10.00%)  2 0/20 (0.00%)  0 2/20 (10.00%)  2
Ear and labyrinth disorders       
Ear pain  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Vertigo  1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Eye disorders       
Dry eye  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Vision blurred  1  0/20 (0.00%)  0 3/20 (15.00%)  3 0/20 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Defaecation urgency  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Dry mouth  1  1/20 (5.00%)  1 1/20 (5.00%)  1 2/20 (10.00%)  2
Nausea  1  8/20 (40.00%)  8 4/20 (20.00%)  5 10/20 (50.00%)  10
Vomiting  1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
General disorders       
Asthenia  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Catheter site inflammation  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Chills  1  3/20 (15.00%)  3 0/20 (0.00%)  0 5/20 (25.00%)  5
Face oedema  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Feeling cold  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Feeling hot  1  1/20 (5.00%)  1 1/20 (5.00%)  1 1/20 (5.00%)  1
Feeling jittery  1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations       
Herpes simplex  1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Myalgia  1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Neck pain  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Nervous system disorders       
Dizziness  1  4/20 (20.00%)  4 2/20 (10.00%)  2 2/20 (10.00%)  4
Headache  1  1/20 (5.00%)  1 8/20 (40.00%)  12 4/20 (20.00%)  5
Paraesthesia  1  4/20 (20.00%)  4 0/20 (0.00%)  0 3/20 (15.00%)  3
Presyncope  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Somnolence  1  0/20 (0.00%)  0 2/20 (10.00%)  2 1/20 (5.00%)  1
Tremor  1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Psychiatric disorders       
Euphoric mood  1  2/20 (10.00%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Insomnia  1  0/20 (0.00%)  0 2/20 (10.00%)  2 2/20 (10.00%)  2
Renal and urinary disorders       
Micturition urgency  1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Pollakiuria  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Urinary hesitation  1  2/20 (10.00%)  2 0/20 (0.00%)  0 1/20 (5.00%)  1
Reproductive system and breast disorders       
Dysmenorrhoea  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Throat irritation  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermal cyst  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Dry skin  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Hyperhidrosis  1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Vascular disorders       
Hot flush  1  1/20 (5.00%)  1 1/20 (5.00%)  1 3/20 (15.00%)  3
Orthostatic hypotension  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01243957     History of Changes
Other Study ID Numbers: 12597
H9P-EW-LNCH ( Other Identifier: Eli Lilly and Company )
First Submitted: November 17, 2010
First Posted: November 19, 2010
Results First Submitted: February 17, 2018
Results First Posted: October 22, 2018
Last Update Posted: January 29, 2019