Trial Outcomes & Findings for A Study of Evacetrapib (LY2484595) in Healthy Participants (NCT NCT01903434)
NCT ID: NCT01903434
Last Updated: 2018-10-09
Results Overview
The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Reference/Test/Test
A single dose of Reference 130 mg evacetrapib on Day 1 of Period 1 and of Test 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3.
There was a washout period of at least 14 days between doses. Each participant received up to 3 doses.
|
Test/Reference/Reference
A single dose of Test 130 mg evacetrapib on Day 1 of Period 1 and of Reference 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3.
There was a washout period of at least 14 days between doses. Each participant received up to 3 doses.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
30
|
30
|
|
Treatment Period 1
Received at Least 1 Dose of Study Drug
|
30
|
30
|
|
Treatment Period 1
COMPLETED
|
30
|
30
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period 1 (at Least 14 Days)
STARTED
|
29
|
28
|
|
Washout Period 1 (at Least 14 Days)
COMPLETED
|
29
|
28
|
|
Washout Period 1 (at Least 14 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
29
|
28
|
|
Treatment Period 2
Received at Least 1 Dose of Study Drug
|
29
|
28
|
|
Treatment Period 2
COMPLETED
|
29
|
28
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 3
STARTED
|
29
|
28
|
|
Treatment Period 3
Received at Least 1 Dose of Study Drug
|
29
|
28
|
|
Treatment Period 3
COMPLETED
|
29
|
28
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Reference/Test/Test
A single dose of Reference 130 mg evacetrapib on Day 1 of Period 1 and of Test 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3.
There was a washout period of at least 14 days between doses. Each participant received up to 3 doses.
|
Test/Reference/Reference
A single dose of Test 130 mg evacetrapib on Day 1 of Period 1 and of Reference 130 mg evacetrapib on Day 1 of Period 2 and Day 1 of Period 3.
There was a washout period of at least 14 days between doses. Each participant received up to 3 doses.
|
|---|---|---|
|
Washout Period 1 (at Least 14 Days)
Adverse Event
|
1
|
0
|
|
Washout Period 1 (at Least 14 Days)
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study of Evacetrapib (LY2484595) in Healthy Participants
Baseline characteristics by cohort
| Measure |
130 mg Evacetrapib
n=60 Participants
Participants randomized to receive a single dose of 130 mg evacetrapib of either of the two different solid fraction controls on Day 1 of each of 3 treatment periods, according to their assigned treatment sequence.
|
|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each periodPopulation: Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.
The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).
Outcome measures
| Measure |
Reference
n=58 Participants
Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.
|
Test
n=59 Participants
Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595)
|
604 nanograms per milliliter
Geometric Coefficient of Variation 76
|
597 nanograms per milliliter
Geometric Coefficient of Variation 102
|
PRIMARY outcome
Timeframe: Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each periodPopulation: Participants who received at least 1 dose of evacetrapib and had evaluable evacetrapib concentration data.
Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC\[0-∞\]) is summarized for each solid fraction control (Reference and Test).
Outcome measures
| Measure |
Reference
n=58 Participants
Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.
|
Test
n=59 Participants
Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595)
|
10400 nanograms times hours per milliliter
Geometric Coefficient of Variation 56
|
10300 nanograms times hours per milliliter
Geometric Coefficient of Variation 68
|
Adverse Events
Reference
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Test
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reference
n=58 participants at risk
Evacetrapib: 130 mg with a solid fraction of 0.86 administered on Day 1 of up to 2 of 3 treatment periods.
|
Test
n=59 participants at risk
Evacetrapib: 130 mg with a solid fraction of 0.89 administered on Day 1 of up to 2 of 3 treatment periods.
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.9%
4/58 • Number of events 4
|
1.7%
1/59 • 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