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A Study to Evaluate the Effect of Clarithromycin on LY2216684

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ClinicalTrials.gov Identifier: NCT01460407
Recruitment Status : Completed
First Posted : October 26, 2011
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
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 Depressive Disorder, Major
Interventions Drug: LY2216684
Drug: Clarithromycin
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LY2216684 LY2216684 and Clarithromycin
Hide Arm/Group Description LY2216684: a single 18-milligram (mg) tablet on Day 1

LY2216684: a single 18-mg tablet on Day 10

Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13

Period Title: Period 1: Day 1 to Day 5
Started 14 0
Completed 14 0
Not Completed 0 0
Period Title: Period 2: Day 6 to Day 14
Started 0 14
Completed 0 13
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description

LY2216684: a single 18-mg tablet on Day 1 and Day 10

Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
43.5  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
6
  42.9%
Male
8
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Hispanic or Latino
7
  50.0%
Not Hispanic or Latino
7
  50.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   7.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
12
  85.7%
More than one race
1
   7.1%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
 100.0%
1.Primary Outcome
Title Pharmacokinetics: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of LY2216684
Hide Description AUC0-∞ of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric Least Squares (LS) mean and the 90% Confidence Interval (CI). Geometric LS mean was controlled by participant and treatment.
Time Frame Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Participants who received at least 1 dose of LY2216684.
Arm/Group Title LY2216684 LY2216684 and Clarithromycin
Hide Arm/Group Description:
LY2216684: a single 18-mg tablet on Day 1

LY2216684: a single 18-mg tablet on Day 10

Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13

Overall Number of Participants Analyzed 14 14
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanogram*hours per milliliter (ng*h/mL)
582
(498 to 681)
746
(638 to 873)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684, LY2216684 and Clarithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS mean
Estimated Value 1.28
Confidence Interval (2-Sided) 90%
1.16 to 1.42
Estimation Comments Ratio of LY2216684 and Clarithromycin to LY2216684
2.Primary Outcome
Title Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY2216684
Hide Description Cmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.
Time Frame Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Participants who received at least 1 dose of LY2216684.
Arm/Group Title LY2216684 LY2216684 and Clarithromycin
Hide Arm/Group Description:
LY2216684: a single 18-mg tablet on Day 1

LY2216684: a single 18-mg tablet on Day 10

Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13

Overall Number of Participants Analyzed 14 14
Geometric Mean (90% Confidence Interval)
Unit of Measure: nanograms per milliliter (ng/mL)
52.58
(46.38 to 59.61)
63.55
(56.06 to 72.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684, LY2216684 and Clarithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric LS mean
Estimated Value 1.21
Confidence Interval (2-Sided) 90%
1.12 to 1.31
Estimation Comments Ratio of LY2216684 and Clarithromycin to LY2216684
3.Primary Outcome
Title Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of LY2216684
Hide Description Tmax of LY2216684 was calculated during Period 1, when 18-mg LY2216684 was administered alone, and Period 2, when Clarithromycin was coadministered with LY2216684. The outcome was presented as geometric LS mean and the 90% CI. Geometric LS mean was controlled by participant and treatment.
Time Frame Predose up to 96 hours post administration of LY2216684 (Day 1) and LY2216684 + Clarithromycin (Day 10)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Participants who received at least 1 dose of LY2216684.
Arm/Group Title LY2216684 LY2216684 and Clarithromycin
Hide Arm/Group Description:
LY2216684: a single 18-mg tablet on Day 1

LY2216684: a single 18-mg tablet on Day 10

Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13

Overall Number of Participants Analyzed 14 14
Median (90% Confidence Interval)
Unit of Measure: hours (h)
2.00
(1.00 to 5.00)
2.00
(2.00 to 4.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LY2216684, LY2216684 and Clarithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7656
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median of paired differences
Estimated Value 0.00
Confidence Interval (2-Sided) 90%
-0.50 to 0.50
Estimation Comments LY2216684 and Clarithromycin minus (-) LY2216684
Time Frame [Not Specified]
Adverse Event Reporting Description

All randomized participants were to receive the following treatment regimen:

LY2216684: a single 18-mg tablet on Day 1 and a single 18-mg tablet on Day 10

Clarithromycin: 500-mg tablet twice daily on Day 6 through Day 13

 
Arm/Group Title LY2216684 LY2216684 and Clarithromycin Clarithromycin
Hide Arm/Group Description Adverse Events (AEs) that occurred from Day 1 postdose to Day 6 prior to dosing for all randomized participants. AEs that occurred from Day 10 postdose to end of study (7 days post last dose) for all randomized participants. AEs that occurred from Day 6 postdose to Day 10 prior to dosing, for all randomized participants.
All-Cause Mortality
LY2216684 LY2216684 and Clarithromycin Clarithromycin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2216684 LY2216684 and Clarithromycin Clarithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)      0/14 (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 LY2216684 and Clarithromycin Clarithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/14 (42.86%)      6/14 (42.86%)      4/14 (28.57%)    
Gastrointestinal disorders       
Abdominal pain  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
Flatulence  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0
Gastrointestinal sounds abnormal  1  1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0
Haematochezia  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
Nausea  1  1/14 (7.14%)  1 2/14 (14.29%)  2 0/14 (0.00%)  0
General disorders       
Chest discomfort  1  0/14 (0.00%)  0 1/14 (7.14%)  1 0/14 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders       
Dizziness  1  1/14 (7.14%)  1 2/14 (14.29%)  2 0/14 (0.00%)  0
Dysgeusia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Headache  1  1/14 (7.14%)  1 1/14 (7.14%)  1 0/14 (0.00%)  0
Psychiatric disorders       
Depressed mood  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Insomnia  1  1/14 (7.14%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1
Renal and urinary disorders       
Urinary hesitation  1  0/14 (0.00%)  0 2/14 (14.29%)  2 0/14 (0.00%)  0
Reproductive system and breast disorders       
Penile discharge  1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dysphonia  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Oropharyngeal pain  1  1/14 (7.14%)  1 0/14 (0.00%)  0 1/14 (7.14%)  1
Skin and subcutaneous tissue disorders       
Erythema  1  0/14 (0.00%)  0 0/14 (0.00%)  0 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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: NCT01460407     History of Changes
Other Study ID Numbers: 14401
H9P-EW-LNEB ( Other Identifier: Eli Lilly and Company )
First Submitted: October 24, 2011
First Posted: October 26, 2011
Results First Submitted: February 17, 2018
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018