Trial Outcomes & Findings for A Study of Different Particle Sizes of Evacetrapib in Healthy Participants (NCT NCT02497391)
NCT ID: NCT02497391
Last Updated: 2018-12-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
95 participants
Primary outcome timeframe
Predose on Day 1,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
Results posted on
2018-12-03
Participant Flow
Participants were randomized to 1 of 6 treatment sequences in a crossover design with 3 treatments; reference, test 1 and test 2. There was a washout period of ≥14 days between each dose. Participants were dosed 3 times during the entire study in periods 1, 2 and 3.
Participant milestones
| Measure |
Sequence 1 (R/T1/T2)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: R Period 2: T1 Period 3: T2
|
Sequence 2 (T1/T2/R)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1(T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T1 Period 2: T2 Period 3: R
|
Sequence 3 (T2/R/T1)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T2 Period 2: R Period 3: T1
|
Sequence 4 (T2/T1/R)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T2 Period 2: T1 Period 3: R
|
Sequence 5 (R/T2/T1)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: R Period 2: T2 Period 3: T1
|
Sequence 6 (T1/R/T2)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T1 Period 2: R Period 3: T2
|
|---|---|---|---|---|---|---|
|
Period 1 (14 Days)
STARTED
|
16
|
15
|
16
|
16
|
16
|
16
|
|
Period 1 (14 Days)
Received at Least 1 Dose of Study Drug
|
16
|
15
|
16
|
16
|
16
|
16
|
|
Period 1 (14 Days)
COMPLETED
|
16
|
15
|
16
|
16
|
16
|
16
|
|
Period 1 (14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 (14 Days)
STARTED
|
16
|
15
|
16
|
16
|
16
|
16
|
|
Period 2 (14 Days)
COMPLETED
|
12
|
14
|
13
|
13
|
14
|
13
|
|
Period 2 (14 Days)
NOT COMPLETED
|
4
|
1
|
3
|
3
|
2
|
3
|
|
Period 3 (14 Days)
STARTED
|
12
|
14
|
13
|
13
|
14
|
13
|
|
Period 3 (14 Days)
COMPLETED
|
12
|
13
|
12
|
13
|
13
|
13
|
|
Period 3 (14 Days)
NOT COMPLETED
|
0
|
1
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1 (R/T1/T2)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: R Period 2: T1 Period 3: T2
|
Sequence 2 (T1/T2/R)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1(T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T1 Period 2: T2 Period 3: R
|
Sequence 3 (T2/R/T1)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T2 Period 2: R Period 3: T1
|
Sequence 4 (T2/T1/R)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T2 Period 2: T1 Period 3: R
|
Sequence 5 (R/T2/T1)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: R Period 2: T2 Period 3: T1
|
Sequence 6 (T1/R/T2)
Single oral dose of evacetrapib 130 mg tablet given one time during one study period as a evacetrapib reference (R1), evacetrapib test 1 (T1) or evacetrapib test 2 (T2) formulation.
All participants received one tablet in Period 1: T1 Period 2: R Period 3: T2
|
|---|---|---|---|---|---|---|
|
Period 2 (14 Days)
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
0
|
|
Period 2 (14 Days)
Sponsor Decision
|
3
|
1
|
2
|
3
|
2
|
3
|
|
Period 3 (14 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3 (14 Days)
Sponsor Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 3 (14 Days)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Different Particle Sizes of Evacetrapib in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Participants
n=95 Participants
Participants received a single dose of 130 mg evacetrapib tablet (a total of 3 doses of evacetrapib) given one time during each study period.
|
|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 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
|
92 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 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
Singapore
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose on Day 1,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 PostdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Evacetrapib Reference (R)
n=84 Participants
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
Evacetrapib Test 1 (T1)
n=81 Participants
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
Evacetrapib Test 2 (T2)
n=85 Participants
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
|
983 nangram/milliliter (ng/mL)
Geometric Coefficient of Variation 78
|
1170 nangram/milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
1120 nangram/milliliter (ng/mL)
Geometric Coefficient of Variation 66
|
PRIMARY outcome
Timeframe: Predose on Day 1,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 PostdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Evacetrapib Reference (R)
n=84 Participants
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
Evacetrapib Test 1 (T1)
n=81 Participants
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
Evacetrapib Test 2 (T2)
n=85 Participants
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib
|
14700 nanogram·hour/milliter (ng·h/mL)
Geometric Coefficient of Variation 53
|
16100 nanogram·hour/milliter (ng·h/mL)
Geometric Coefficient of Variation 45
|
15500 nanogram·hour/milliter (ng·h/mL)
Geometric Coefficient of Variation 49
|
Adverse Events
Evacetrapib Reference (R)
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Evacetrapib Test 1 (T1)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Evacetrapib Test 2 (T2)
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Evacetrapib Reference (R)
n=84 participants at risk
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
Evacetrapib Test 1 (T1)
n=81 participants at risk
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
Evacetrapib Test 2 (T2)
n=85 participants at risk
Single oral dose of evacetrapib 130 mg tablet given one time during one study period.
|
|---|---|---|---|
|
General disorders
Catheter site related reaction
|
15.5%
13/84 • Number of events 13
|
11.1%
9/81 • Number of events 9
|
2.4%
2/85 • Number of events 2
|
|
General disorders
Vessel puncture site bruise
|
19.0%
16/84 • Number of events 17
|
14.8%
12/81 • Number of events 13
|
23.5%
20/85 • Number of events 21
|
|
Nervous system disorders
Headache
|
7.1%
6/84 • Number of events 6
|
6.2%
5/81 • Number of events 5
|
2.4%
2/85 • Number of events 2
|
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