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Trial record 10 of 27 for:    Edivoxetine OR LY2216684

A Pharmacokinetic Study of the Coadministration of LY2216684 With Sertraline

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ClinicalTrials.gov Identifier: NCT01250873
Recruitment Status : Completed
First Posted : December 1, 2010
Results First Posted : October 19, 2018
Last Update Posted : January 4, 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: Sertraline
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2216684/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Period Title: Period 1: LY2216684 (Days 1-3)
Started 20
Completed 18
Not Completed 2
Reason Not Completed
Adverse Event             2
Period Title: Period 2: Sertraline (Day 4, 5-10)
Started 18
Completed 18
Not Completed 0
Period Title: Period 3:LY2216684+Sertraline(Days11-13)
Started 18
Completed 17
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title LY2216684/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
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
37.8  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
12
  60.0%
Not Hispanic or Latino
8
  40.0%
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
3
  15.0%
White
13
  65.0%
More than one race
4
  20.0%
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 LY221684 was administered alone (Day 3) and when LY2216684 was coadministered with sertraline (Day 13). The Day 13-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 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13
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/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description:
Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Overall Number of Participants Analyzed 18
Geometric Least Squares Mean (90% Confidence Interval)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
LY2216684 alone Number Analyzed 18 participants
675
(618 to 738)
LY2216684 + sertraline Number Analyzed 13 participants
792
(716 to 876)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684/Sertraline/LY2216684 + Sertraline
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 1.17
Confidence Interval (2-Sided) 90%
1.06 to 1.30
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 sertraline (Day 13). The Day 13-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 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13
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/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description:
Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Overall Number of Participants Analyzed 18
Geometric Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram per milliliter (ng/mL)
LY2216684 alone Number Analyzed 18 participants
65.9
(60.9 to 71.4)
LY2216684 + sertraline Number Analyzed 13 participants
74.9
(68.1 to 82.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684/Sertraline/LY2216684 + Sertraline
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 1.14
Confidence Interval (2-Sided) 90%
1.01 to 1.28
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 sertraline (Day 13). The 90% confidence interval (CI) for the median of differences was calculated.
Time Frame 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 3 and Day 13
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/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description:
Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Overall Number of Participants Analyzed 13
Median (90% Confidence Interval)
Unit of Measure: hours
LY2216684 alone
2.00
(2.00 to 4.00)
LY2216684 + sertraline
3.00
(2.00 to 4.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684/Sertraline/LY2216684 + Sertraline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8281
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 1.00
Estimation Comments [Not Specified]
4.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-Time Curve Over a 24-Hour Dosing Interval (AUCτ) of Sertraline
Hide Description The Least Squares (LS) geometric mean AUCτ of sertraline was calculated based on the sertraline plasma concentration time curve from time 0 hour (hr) to time 24 hr (tau [τ]) when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The Day 13-to-Day 10 ratio of the sertraline LS geometric mean of AUCτ and the associated 90% confidence interval (CI) of the ratio were calculated.
Time Frame 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13
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/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description:
Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Overall Number of Participants Analyzed 17
Geometric Least Squares Mean (90% Confidence Interval)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
sertraline alone Number Analyzed 17 participants
1240
(1090 to 1400)
sertraline + LY2216684 Number Analyzed 13 participants
1570
(1380 to 1790)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684/Sertraline/LY2216684 + Sertraline
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 1.27
Confidence Interval (2-Sided) 90%
1.17 to 1.39
Estimation Comments [Not Specified]
5.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax) of Sertraline
Hide Description The Least Squares (LS) geometric mean Cmax of sertraline was determined when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The Day 13-to-Day 10 ratio of the sertraline LS geometric mean of Cmax and the associated 90% confidence interval (CI) of the ratio were calculated.
Time Frame 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13
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/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description:
Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Overall Number of Participants Analyzed 17
Geometric Least Squares Mean (90% Confidence Interval)
Unit of Measure: nanogram per milliliter (ng/mL)
sertraline alone Number Analyzed 17 participants
70.7
(62.4 to 80.1)
sertraline + LY2216684 Number Analyzed 13 participants
86.4
(75.6 to 98.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684/Sertraline/LY2216684 + Sertraline
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 1.22
Confidence Interval (2-Sided) 90%
1.10 to 1.36
Estimation Comments [Not Specified]
6.Primary Outcome
Title Pharmacokinetic (PK) Parameter: Time to Maximum Plasma Concentration (Tmax) of Sertraline
Hide Description Tmax of sertraline was determined using the median of paired differences between the 2 treatment groups when sertraline was administered alone (Day 10) and when sertraline was coadministered with LY2216684 (Day 13). The 90% confidence interval (CI) for the median of differences was calculated.
Time Frame 0, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10 and Day 13
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/Sertraline/LY2216684 + Sertraline
Hide Arm/Group Description:
Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
Overall Number of Participants Analyzed 13
Median (90% Confidence Interval)
Unit of Measure: hours
sertraline alone
6.00
(2.00 to 12.00)
sertraline + LY2216684
8.00
(6.00 to 8.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684/Sertraline/LY2216684 + Sertraline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3125
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.00
Confidence Interval (2-Sided) 90%
0.00 to 2.00
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LY2216684 Sertraline LY2216684 + Sertraline
Hide Arm/Group Description Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3; Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10; Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13. Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10. Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.
All-Cause Mortality
LY2216684 Sertraline LY2216684 + Sertraline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 Sertraline LY2216684 + Sertraline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/18 (0.00%)      0/18 (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 Sertraline LY2216684 + Sertraline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/20 (55.00%)      6/18 (33.33%)      13/18 (72.22%)    
Ear and labyrinth disorders       
Vertigo  1  1/20 (5.00%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Eye disorders       
Dry eye  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Constipation  1  3/20 (15.00%)  3 0/18 (0.00%)  0 0/18 (0.00%)  0
Diarrhoea haemorrhagic  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Dyspepsia  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Flatulence  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Nausea  1  2/20 (10.00%)  2 0/18 (0.00%)  0 3/18 (16.67%)  3
Vomiting  1  1/20 (5.00%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
General disorders       
Chills  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Feeling of body temperature change  1  6/20 (30.00%)  7 0/18 (0.00%)  0 1/18 (5.56%)  1
Irritability  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Pain  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Infections and infestations       
Cellulitis  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Herpes zoster  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Lower respiratory tract infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Pharyngitis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Rhinitis  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Sinusitis  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/18 (0.00%)  0
Metabolism and nutrition disorders       
Hyperphagia  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Costochondritis  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Groin pain  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Myalgia  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Nervous system disorders       
Disturbance in attention  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Dizziness  1  0/20 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2
Headache  1  2/20 (10.00%)  2 3/18 (16.67%)  4 2/18 (11.11%)  2
Presyncope  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/18 (0.00%)  0
Somnolence  1  1/20 (5.00%)  1 0/18 (0.00%)  0 2/18 (11.11%)  2
Psychiatric disorders       
Anxiety  1  1/20 (5.00%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Insomnia  1  1/20 (5.00%)  1 0/18 (0.00%)  0 1/18 (5.56%)  1
Renal and urinary disorders       
Dysuria  1  2/20 (10.00%)  2 0/18 (0.00%)  0 0/18 (0.00%)  0
Semenuria  1  2/20 (10.00%)  2 1/18 (5.56%)  1 1/18 (5.56%)  1
Urinary retention  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Reproductive system and breast disorders       
Testicular pain  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/20 (0.00%)  0 1/18 (5.56%)  1 1/18 (5.56%)  1
Dyspnoea  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Oropharyngeal pain  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/18 (5.56%)  1
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Pruritus  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Rash  1  0/20 (0.00%)  0 0/18 (0.00%)  0 2/18 (11.11%)  2
Vascular disorders       
Flushing  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Vasodilatation  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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: NCT01250873     History of Changes
Other Study ID Numbers: 12611
H9P-EW-LNCT ( Other Identifier: Eli Lilly and Company )
First Submitted: November 29, 2010
First Posted: December 1, 2010
Results First Submitted: February 17, 2018
Results First Posted: October 19, 2018
Last Update Posted: January 4, 2019