Trial Outcomes & Findings for A Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants (NCT NCT01825876)
NCT ID: NCT01825876
Last Updated: 2018-10-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
15 mg Warfarin
15 milligram (mg) warfarin administered as a single oral dose on Day 1
|
130 mg Evacetrapib + 15 mg Warfarin
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 1
STARTED
|
17
|
0
|
|
Period 1
Received 1 Dose of Study Drug
|
17
|
0
|
|
Period 1
COMPLETED
|
17
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
0
|
17
|
|
Period 2
Received 1 Dose of Study Drug
|
0
|
17
|
|
Period 2
COMPLETED
|
0
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
15 mg Warfarin
15 milligram (mg) warfarin administered as a single oral dose on Day 1
|
130 mg Evacetrapib + 15 mg Warfarin
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 2
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study of Evacetrapib (LY2484595) and Warfarin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=17 Participants
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.
|
|---|---|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dosePopulation: All participants who received a dose of study drug and had evaluable data for AUC(0-∞).
Outcome measures
| Measure |
130 mg Evacetrapib + 15 mg Warfarin
n=16 Participants
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
|
Warfarin
n=17 Participants
15 mg warfarin administered as a single oral dose
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of S-Warfarin
|
126 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 39
|
132 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 35
|
PRIMARY outcome
Timeframe: Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dosePopulation: All participants who received a dose of study drug and had evaluable data for Cmax.
Outcome measures
| Measure |
130 mg Evacetrapib + 15 mg Warfarin
n=16 Participants
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
|
Warfarin
n=17 Participants
15 mg warfarin administered as a single oral dose
|
|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of S-Warfarin
|
4.72 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
4.69 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
SECONDARY outcome
Timeframe: Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dosePopulation: All participants who received a dose of study drug and had evaluable data for AUC(0-∞).
Outcome measures
| Measure |
130 mg Evacetrapib + 15 mg Warfarin
n=16 Participants
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
|
Warfarin
n=17 Participants
15 mg warfarin administered as a single oral dose
|
|---|---|---|
|
PK: AUC0-∞ of R-Warfarin
|
314 ng*h/mL
Geometric Coefficient of Variation 25
|
321 ng*h/mL
Geometric Coefficient of Variation 25
|
SECONDARY outcome
Timeframe: Days 1 and 17: 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dosePopulation: All participants who received a dose of study drug and had evaluable data for Cmax.
Outcome measures
| Measure |
130 mg Evacetrapib + 15 mg Warfarin
n=16 Participants
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
|
Warfarin
n=17 Participants
15 mg warfarin administered as a single oral dose
|
|---|---|---|
|
PK: Cmax of R-Warfarin
|
6.22 ng/mL
Geometric Coefficient of Variation 15
|
6.02 ng/mL
Geometric Coefficient of Variation 19
|
SECONDARY outcome
Timeframe: Days 1 and 17: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dosePopulation: All participants who received a dose of study drug and had evaluable data for AUCINR.
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.
Outcome measures
| Measure |
130 mg Evacetrapib + 15 mg Warfarin
n=14 Participants
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
|
Warfarin
n=16 Participants
15 mg warfarin administered as a single oral dose
|
|---|---|---|
|
Pharmacodynamics (PD): Area Under the International Normalized Ratio Curve (AUCINR) of Warfarin
|
162 ratio*h
Geometric Coefficient of Variation 5.2
|
167 ratio*h
Geometric Coefficient of Variation 7.9
|
SECONDARY outcome
Timeframe: 0, 6, 12, 24, 36, 48, 72, 96, 120, and 144 hours following warfarin dose on Days 1 and 17Population: All participants who received a dose of study drug and had evaluable data for INRmax.
The INR is a standardized ratio of the PT, time it takes for blood to clot.
Outcome measures
| Measure |
130 mg Evacetrapib + 15 mg Warfarin
n=16 Participants
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
|
Warfarin
n=17 Participants
15 mg warfarin administered as a single oral dose
|
|---|---|---|
|
PD: Maximum Observed INR Response (INRmax) of Warfarin
|
1.25 ratio
Geometric Coefficient of Variation 12.9
|
1.36 ratio
Geometric Coefficient of Variation 17.4
|
Adverse Events
15 mg Warfarin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
130 mg Evacetrapib
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
130 mg Evacetrapib + 15 mg Warfarin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
15 mg Warfarin
n=17 participants at risk
15 mg warfarin administered as a single oral dose on Day 1
|
130 mg Evacetrapib
n=17 participants at risk
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22
|
130 mg Evacetrapib + 15 mg Warfarin
n=16 participants at risk
130 mg evacetrapib alone administered QD, orally, on Days 7 to 22 and with 15 mg warfarin co-administered once orally on Day 17
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
0.00%
0/17
|
0.00%
0/17
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/16
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.9%
1/17 • Number of events 1
|
0.00%
0/17
|
0.00%
0/16
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/17
|
0.00%
0/17
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17
|
5.9%
1/17 • Number of events 1
|
0.00%
0/16
|
|
General disorders
Vessel puncture site haemorrhage
|
11.8%
2/17 • Number of events 3
|
0.00%
0/17
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/17
|
0.00%
0/17
|
6.2%
1/16 • Number of events 1
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60