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Trial record 39 of 733 for:    warfarin

Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02161731
Recruitment Status : Completed
First Posted : June 12, 2014
Results First Posted : October 3, 2018
Last Update Posted : October 3, 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 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Warfarin Evacetrapib + Warfarin
Hide Arm/Group Description 15 milligram (mg) warfarin administered as a single oral dose on Day 1. Evacetrapib administered once daily (QD), orally, for 16 days on Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
Period Title: Period 1 (Day -1 to Day 7 Predose)
Started 24 0
Received 1 Dose of Study Drug 24 0
Completed 24 0
Not Completed 0 0
Period Title: Period 2 (Day 7 Dosing to Day 23)
Started 0 24
Received 1 Dose of Study Drug 0 24
Completed 0 22
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Adverse Event             0             1
Arm/Group Title Warfarin Then Evacetrapib + Warfarin
Hide Arm/Group Description 15 mg warfarin administered as a single oral dose on Day 1. Evacetrapib administered QD, orally, for 16 days, Days 7- 22 with 15 mg warfarin co-administered once orally on Day 17.
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
36.0  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female 0
Male 24
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino 1
Not Hispanic or Latino 23
Unknown or Not Reported 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native 0
Asian 3
Native Hawaiian or Other Pacific Islander 0
Black or African American 11
White 9
More than one race 1
Unknown or Not Reported 0
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) 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 on Day 1.
Evacetrapib administered QD, orally, for 16 days, Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
Overall Number of Participants Analyzed 24 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter (ng*h/mL)
128
(23%)
114
(19%)
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 Warfarin Evacetrapib + Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1.
Evacetrapib administered QD, orally, for 16 days, Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
Overall Number of Participants Analyzed 24 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter (ng/mL)
4.20
(21%)
4.34
(29%)
3.Secondary Outcome
Title PK: AUC[0-∞] 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 Warfarin Evacetrapib + Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1.
Evacetrapib administered QD, orally, for 16 days, Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
Overall Number of Participants Analyzed 24 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
287
(16%)
271
(17%)
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 of R- enantiomers of Warfarin.
Arm/Group Title Warfarin Evacetrapib + Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1.
Evacetrapib administered QD, orally, for 16 days, Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
Overall Number of Participants Analyzed 24 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
5.03
(21%)
5.27
(27%)
5.Secondary Outcome
Title Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUC[INR]) of Warfarin
Hide Description The INR is a standardized ratio of the prothrombin time (PT), time it takes for blood to clot. AUC[INR] is the time curve used to measure change in INR over time.
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[INR].
Arm/Group Title Warfarin Evacetrapib + Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1.
Evacetrapib administered QD, orally, for 16 days, Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
Overall Number of Participants Analyzed 24 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio times hour (ratio*h)
174
(7.0%)
165
(5.0%)
6.Secondary Outcome
Title PD: Maximum Observed International Normalized Ratio Response (INRmax) of Warfarin
Hide Description [Not Specified]
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 date for INRmax.
Arm/Group Title Warfarin Evacetrapib + Warfarin
Hide Arm/Group Description:
15 mg warfarin administered as a single oral dose on Day 1.
Evacetrapib administered QD, orally, for 16 days, Days 7 - 22 with 15 mg warfarin co-administered once orally on Day 17.
Overall Number of Participants Analyzed 24 23
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
1.47
(18%)
1.34
(11%)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 15 mg Warfarin 130 mg Evacetrapib 15 mg Warfarin + 130 mg Evacetrapib
Hide Arm/Group Description 15 milligram (mg) warfarin administered as a single oral dose on Day 1. 130 mg Evacetrapib administered once daily (QD), orally, for 16 days, Days 7 - 22. Evacetrapib administered once daily (QD), orally, for 16 days, Days 7 - 22 with 15 milligram (mg) warfarin co-administered once orally on Day 17.
All-Cause Mortality
15 mg Warfarin 130 mg Evacetrapib 15 mg Warfarin + 130 mg Evacetrapib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
15 mg Warfarin 130 mg Evacetrapib 15 mg Warfarin + 130 mg Evacetrapib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/24 (0.00%)      0/23 (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 15 mg Warfarin + 130 mg Evacetrapib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      2/24 (8.33%)      0/23 (0.00%)    
Skin and subcutaneous tissue disorders       
Pruritus  1  0/24 (0.00%)  0 2/24 (8.33%)  3 0/23 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
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: NCT02161731     History of Changes
Other Study ID Numbers: 15366
I1V-MC-EIBN ( Other Identifier: Eli Lilly and Company )
First Submitted: June 10, 2014
First Posted: June 12, 2014
Results First Submitted: February 18, 2018
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018