Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 27 for:    Edivoxetine OR LY2216684

A Study to Evaluate the Effect of Food on LY2216684

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: NCT01389765
Recruitment Status : Completed
First Posted : July 8, 2011
Results First Posted : November 12, 2018
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depressive Disorder, Major
Intervention Drug: LY2216684
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2216684 During Fed, Then LY2216684 During Fasting State LY2216684 During Fasting, Then LY2216684 During Fed State
Hide Arm/Group Description In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fasting state. Periods were separated by a 7-day washout period. In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in fasting state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the fed state. Periods were separated by a 7-day washout period.
Period Title: First Intervention (Day 1)
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Washout Period (7 Days)
Started 12 12
Completed 12 12
Not Completed 0 0
Period Title: Second Intervention (Day 1)
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Overall
Hide Arm/Group Description In Period 1, participants received a single oral dose of 18 milligram (mg) LY2216684, administered in either fasted or fed state. In Period 2, participants received a single oral dose of 18 mg LY2216684, administered in the alternative feeding state that was not used during Period 1 (fasted or fed). Periods were separated by a 7-day washout period.
Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
39.0  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
13
  54.2%
Male
11
  45.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
10
  41.7%
Not Hispanic or Latino
14
  58.3%
Unknown or Not Reported
0
   0.0%
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
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
9
  37.5%
White
12
  50.0%
More than one race
3
  12.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
 100.0%
1.Primary Outcome
Title Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
Hide Description The AUC for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric Least Squares (LS) means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for AUC.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a baseline observation and at least 1 post-baseline observation.
Arm/Group Title LY2216684 Administered in Fed State LY2216684 Administered in Fasted State
Hide Arm/Group Description:
Participants received a single oral dose of 18 mg LY2216684 in fed state.
Participants received a single oral dose of 18 mg LY2216684 in fasted state.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram*hour/milliliter (ng*h/mL)
871
(779 to 973)
861
(771 to 962)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 Administered in Fed State, LY2216684 Administered in Fasted State
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 Mixed Models Analysis
Comments Analyzed was a ratio of geometric LS means between the 2 treatment states (fed/fasted), and the 90% confidence interval for the ratio.
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 1.01
Confidence Interval (2-Sided) 90%
0.97 to 1.05
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
Hide Description The Cmax for LY2216684 was calculated for LY2216684 administered in fed state (test) and LY2216684 administered in fasted state (reference). Geometric LS means were calculated according to the following model: Log(PK) = sequence + period + treatment + subject + random error for Cmax.
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a baseline observation and at least 1 post-baseline observation.
Arm/Group Title LY2216684 Administered in Fed State LY2216684 Administered in Fasted State
Hide Arm/Group Description:
Participants received a single oral dose of 18 mg LY2216684 in fed state.
Participants received a single oral dose of 18 mg LY2216684 in fasted state.
Overall Number of Participants Analyzed 24 24
Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram/milliliter (ng/mL)
66.04
(59.85 to 72.88)
68.68
(62.24 to 75.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 Administered in Fed State, LY2216684 Administered in Fasted State
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 Mixed Models Analysis
Comments Analyzed was a ratio of geometric LS means between the 2 treatments states (fed/fasted), and the 90% confidence interval for the ratio.
Method of Estimation Estimation Parameter Ratio of Geometric Least Squares Means
Estimated Value 0.96
Confidence Interval (2-Sided) 90%
0.92 to 1.01
Estimation Comments [Not Specified]
3.Primary Outcome
Title Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 24, 48, 72 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with a baseline observation and at least 1 post-baseline observation.
Arm/Group Title LY2216684 Administered in Fed State LY2216684 Administered in Fasted State
Hide Arm/Group Description:
Participants received a single oral dose of 18 mg LY2216684 in fed state.
Participants received a single oral dose of 18 mg LY2216684 in fasted state.
Overall Number of Participants Analyzed 24 24
Median (Full Range)
Unit of Measure: hours
3.00
(1.00 to 6.00)
2.00
(1.00 to 3.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684 Administered in Fed State, LY2216684 Administered in Fasted State
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Analyzed were the median of paired differences between the 2 treatment states (fed versus fasted) and the 90% confidence interval.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
0.50 to 1.50
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2216684 Administered in Fed State LY2216684 Administered in Fasted State
Hide Arm/Group Description Participants received a single oral dose of 18 mg LY2216684 in fed state. Participants received a single oral dose of 18 mg LY2216684 in fasted state.
All-Cause Mortality
LY2216684 Administered in Fed State LY2216684 Administered in Fasted State
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 Administered in Fed State LY2216684 Administered in Fasted State
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
LY2216684 Administered in Fed State LY2216684 Administered in Fasted State
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/24 (29.17%)      6/24 (25.00%)    
Cardiac disorders     
Palpitations  1  0/24 (0.00%)  0 1/24 (4.17%)  1
Tachycardia  1  0/24 (0.00%)  0 1/24 (4.17%)  1
Ear and labyrinth disorders     
Tinnitus  1  1/24 (4.17%)  1 0/24 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/24 (4.17%)  1 0/24 (0.00%)  0
Nausea  1  0/24 (0.00%)  0 2/24 (8.33%)  2
General disorders     
Asthenia  1  1/24 (4.17%)  1 0/24 (0.00%)  0
Fatigue  1  1/24 (4.17%)  1 2/24 (8.33%)  2
Injury, poisoning and procedural complications     
Scratch  1  0/24 (0.00%)  0 1/24 (4.17%)  1
Nervous system disorders     
Dizziness  1  1/24 (4.17%)  1 1/24 (4.17%)  1
Head discomfort  1  0/24 (0.00%)  0 1/24 (4.17%)  1
Headache  1  3/24 (12.50%)  3 0/24 (0.00%)  0
Renal and urinary disorders     
Pollakiuria  1  1/24 (4.17%)  1 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  1/24 (4.17%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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: NCT01389765     History of Changes
Other Study ID Numbers: 12620
H9P-EW-LNDC ( Other Identifier: Eli Lilly and Company )
First Submitted: July 6, 2011
First Posted: July 8, 2011
Results First Submitted: February 17, 2018
Results First Posted: November 12, 2018
Last Update Posted: November 12, 2018