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Trial record 47 of 736 for:    warfarin

A Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT01825876
Recruitment Status : Completed
First Posted : April 8, 2013
Results First Posted : October 8, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Evacetrapib
Drug: Warfarin
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib + 15 mg Warfarin
Hide Arm/Group Description 15 milligram (mg) warfarin administered as a single oral dose on Day 1 130 mg evacetrapib alone administered once daily (QD), orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
Period Title: Period 1
Started 17 0
Received 1 Dose of Study Drug 17 0
Completed 17 0
Not Completed 0 0
Period Title: Period 2
Started 0 [1] 17 [2]
Received 1 Dose of Study Drug 0 17
Completed 0 16
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
[1]
Participants received a different treatment in Period 2.
[2]
Participants received a different treatment in Period 1.
Arm/Group Title Overall Study
Hide Arm/Group Description Participants were administered 15 mg warfarin as a single oral dose on Days 1 and 17; 130 mg evacetrapib was administered QD, orally, on Days 7 to 22.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
38.2  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
1
   5.9%
Male
16
  94.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Hispanic or Latino
4
  23.5%
Not Hispanic or Latino
13
  76.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 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
4
  23.5%
White
13
  76.5%
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 17 participants
17
1.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of S-Warfarin
Hide Description [Not Specified]
Time Frame Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug and had evaluable data for AUC(0-∞).
Arm/Group Title Warfarin Evacetrapib + Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
Overall Number of Participants Analyzed 17 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms*hour/milliliter (ng*h/mL)
132
(35%)
126
(39%)
2.Primary Outcome
Title PK: Maximum Observed Concentration (Cmax) of S-Warfarin
Hide Description [Not Specified]
Time Frame Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug and had evaluable data for Cmax.
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib + 15 mg Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
Overall Number of Participants Analyzed 17 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter (ng/mL)
4.69
(20%)
4.72
(15%)
3.Secondary Outcome
Title PK: AUC0-∞ of R-Warfarin
Hide Description [Not Specified]
Time Frame Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug and had evaluable data for AUC(0-∞).
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib + 15 mg Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
Overall Number of Participants Analyzed 17 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
321
(25%)
314
(25%)
4.Secondary Outcome
Title PK: Cmax of R-Warfarin
Hide Description [Not Specified]
Time Frame Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug and had evaluable data for Cmax.
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib + 15 mg Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
Overall Number of Participants Analyzed 17 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
6.02
(19%)
6.22
(15%)
5.Secondary Outcome
Title Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin
Hide Description The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUCINR is the time curve used to measure change in INR over time.
Time Frame Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug and had evaluable data for AUCINR.
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib + 15 mg Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
Overall Number of Participants Analyzed 16 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio*h
167
(7.9%)
162
(5.2%)
6.Secondary Outcome
Title PD: Maximum Observed INR Response (INRmax) of Warfarin
Hide Description The INR is a standardized ratio of the PT, time it takes for blood to clot.
Time Frame 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose on Days 1 and 17
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received a dose of study drug and had evaluable data for INRmax.
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib + 15 mg Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
Overall Number of Participants Analyzed 17 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.36
(17.4%)
1.25
(12.9%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib 130 mg Evacetrapib + 15 mg Warfarin
Hide Arm/Group Description 15 mg warfarin administered as a single oral dose on Day 1 130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
All-Cause Mortality
15 mg Warfarin 130 mg Evacetrapib 130 mg Evacetrapib + 15 mg Warfarin
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
15 mg Warfarin 130 mg Evacetrapib 130 mg Evacetrapib + 15 mg Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/17 (0.00%)      0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
15 mg Warfarin 130 mg Evacetrapib 130 mg Evacetrapib + 15 mg Warfarin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/17 (29.41%)      2/17 (11.76%)      4/16 (25.00%)    
Blood and lymphatic system disorders       
Lymphadenopathy  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders       
Constipation  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0
General disorders       
Vessel puncture site haemorrhage  1  2/17 (11.76%)  3 0/17 (0.00%)  0 2/16 (12.50%)  2
Infections and infestations       
Tooth abscess  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  1
Injury, poisoning and procedural complications       
Contusion  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0
Nail injury  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0
Nervous system disorders       
Headache  1  0/17 (0.00%)  0 0/17 (0.00%)  0 1/16 (6.25%)  2
Skin and subcutaneous tissue disorders       
Acne  1  0/17 (0.00%)  0 1/17 (5.88%)  1 0/16 (0.00%)  0
Ecchymosis  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0
Erythema  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0
Papule  1  1/17 (5.88%)  1 0/17 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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
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: NCT01825876     History of Changes
Other Study ID Numbers: 14616
I1V-MC-EIAO ( Other Identifier: Eli Lilly and Company )
First Submitted: April 3, 2013
First Posted: April 8, 2013
Results First Submitted: February 18, 2018
Results First Posted: October 8, 2018
Last Update Posted: October 8, 2018