Trial Outcomes & Findings for A Study of Evacetrapib in Healthy Japanese Participants (NCT NCT02226653)
NCT ID: NCT02226653
Last Updated: 2018-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4
Results posted on
2018-11-08
Participant Flow
Periods 1 to 4 participants are in the fasting state and Period 5 participants were fed a low fat meal. There were two fixed sequences for Test (T) and Reference (R) doses with each participant receiving 5 doses. There was a washout period of at least 21 days between doses.
Participant milestones
| Measure |
Reference/Test/Reference/Test/Test
Reference (R) dose is a single oral dose of one - 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Test (T) dose is a single oral dose of Test two - 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
|
Test/Reference/Test/Reference/Reference
Test (T) dose is a single oral dose of two - 65 milligram (mg) tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Reference (R) is a single oral dose of Reference (R) one - 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
|
|---|---|---|
|
Treatment Period 1 Fasted State
STARTED
|
24
|
24
|
|
Treatment Period 1 Fasted State
Received at Least 1 Dose of Study Drug
|
24
|
24
|
|
Treatment Period 1 Fasted State
COMPLETED
|
24
|
24
|
|
Treatment Period 1 Fasted State
NOT COMPLETED
|
0
|
0
|
|
Washout Period 1 (at Least 21 Days)
STARTED
|
24
|
24
|
|
Washout Period 1 (at Least 21 Days)
COMPLETED
|
24
|
24
|
|
Washout Period 1 (at Least 21 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 Fasted State
STARTED
|
24
|
24
|
|
Treatment Period 2 Fasted State
Received at Least 1 Dose of Study Drug
|
24
|
24
|
|
Treatment Period 2 Fasted State
COMPLETED
|
23
|
24
|
|
Treatment Period 2 Fasted State
NOT COMPLETED
|
1
|
0
|
|
Washout Period 2 (at Least 21 Days)
STARTED
|
23
|
24
|
|
Washout Period 2 (at Least 21 Days)
COMPLETED
|
23
|
24
|
|
Washout Period 2 (at Least 21 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 3 Fasted State
STARTED
|
23
|
24
|
|
Treatment Period 3 Fasted State
Received at Least 1 Dose of Study Drug
|
23
|
24
|
|
Treatment Period 3 Fasted State
COMPLETED
|
23
|
24
|
|
Treatment Period 3 Fasted State
NOT COMPLETED
|
0
|
0
|
|
Washout Period 3 (at Least 21 Days)
STARTED
|
23
|
24
|
|
Washout Period 3 (at Least 21 Days)
COMPLETED
|
23
|
24
|
|
Washout Period 3 (at Least 21 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 4 Fasted State
STARTED
|
23
|
24
|
|
Treatment Period 4 Fasted State
Received at Least 1 Dose of Study Drug
|
23
|
24
|
|
Treatment Period 4 Fasted State
COMPLETED
|
23
|
24
|
|
Treatment Period 4 Fasted State
NOT COMPLETED
|
0
|
0
|
|
Washout Period 4 (at Least 21 Days)
STARTED
|
23
|
24
|
|
Washout Period 4 (at Least 21 Days)
COMPLETED
|
23
|
24
|
|
Washout Period 4 (at Least 21 Days)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 5 Fed State
STARTED
|
23
|
24
|
|
Treatment Period 5 Fed State
Received at Least 1 Dose of Study Drug
|
23
|
24
|
|
Treatment Period 5 Fed State
COMPLETED
|
23
|
23
|
|
Treatment Period 5 Fed State
NOT COMPLETED
|
0
|
1
|
|
Washout Period 5 (at Least 21 Days)
STARTED
|
23
|
23
|
|
Washout Period 5 (at Least 21 Days)
COMPLETED
|
23
|
23
|
|
Washout Period 5 (at Least 21 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Reference/Test/Reference/Test/Test
Reference (R) dose is a single oral dose of one - 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Test (T) dose is a single oral dose of Test two - 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
|
Test/Reference/Test/Reference/Reference
Test (T) dose is a single oral dose of two - 65 milligram (mg) tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Reference (R) is a single oral dose of Reference (R) one - 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
|
|---|---|---|
|
Treatment Period 2 Fasted State
Lost to Follow-up
|
1
|
0
|
|
Treatment Period 5 Fed State
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of Evacetrapib in Healthy Japanese Participants
Baseline characteristics by cohort
| Measure |
Reference/Test/Reference/Test/Test
n=24 Participants
Reference(R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
|
Test/Reference/Test/Reference/Reference
n=24 Participants
Test (T) dose is a single oral dose of Test 2 two- 65 mg tablets of evacetrapib on Day 1 of Period 1 and Day 1 of Period 3. Then, Reference (R) dose is a single oral dose of Reference 1 one- 130 mg tablet of evacetrapib on Day 1 of Period 2, Day 1 of Period 4 and Day 1 of Period 5. There was a washout period of at least 21 days between doses.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
34.7 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4Population: All randomized participants who completed and had evaluable AUC(0-∞) bioequivalence fasted state data for Periods 1,2,3 and 4.
Outcome measures
| Measure |
Reference (Fasted)
n=45 Participants
Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.
|
Test (Fasted)
n=45 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.
|
Test (Fasted)
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.
|
Test (Fed)
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)
|
14600 nanogram·hour/milliliter (ng·h/mL)
Geometric Coefficient of Variation 40
|
14600 nanogram·hour/milliliter (ng·h/mL)
Geometric Coefficient of Variation 36
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4Population: All randomized participants who completed and had evaluable Cmax bioequivalence fasted state data for Periods 1,2,3 and 4.
Outcome measures
| Measure |
Reference (Fasted)
n=45 Participants
Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.
|
Test (Fasted)
n=45 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.
|
Test (Fasted)
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.
|
Test (Fed)
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
|
|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)
|
1130 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 53
|
1100 nanogram/milliliter (ng/ml)
Geometric Coefficient of Variation 40
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5Population: All randomized participants who completed and had evaluable Tmax Fasted and Fed State data for Periods 2, 4, and 5.
Outcome measures
| Measure |
Reference (Fasted)
n=23 Participants
Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.
|
Test (Fasted)
n=23 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.
|
Test (Fasted)
n=22 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.
|
Test (Fed)
n=22 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
|
|---|---|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)
|
3.75 hour (h)
Interval 1.75 to 5.0
|
2.50 hour (h)
Interval 1.5 to 5.5
|
3.50 hour (h)
Interval 2.25 to 5.0
|
2.75 hour (h)
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5Population: All randomized participants who completed and had evaluable AUC(0-∞) Fasted and Fed State data for Periods 2,4, and 5.
Outcome measures
| Measure |
Reference (Fasted)
n=23 Participants
Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.
|
Test (Fasted)
n=23 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.
|
Test (Fasted)
n=22 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.
|
Test (Fed)
n=22 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
|
|---|---|---|---|---|
|
PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)
|
14800 ng·h/mL
Geometric Coefficient of Variation 39
|
18900 ng·h/mL
Geometric Coefficient of Variation 24
|
14600 ng·h/mL
Geometric Coefficient of Variation 39
|
18600 ng·h/mL
Geometric Coefficient of Variation 26
|
SECONDARY outcome
Timeframe: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5Population: All randomized participants who completed and had evaluable Cmax Fasted and Fed State data for Periods 2,4, and 5.
Outcome measures
| Measure |
Reference (Fasted)
n=23 Participants
Reference dose is a single oral dose of Reference one- 130mg tablets of evacetrapib in fasted state in Period 1, 2, 3 and 4.
|
Test (Fasted)
n=23 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3 and 4.
|
Test (Fasted)
n=22 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 2 and 4.
|
Test (Fed)
n=22 Participants
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
|
|---|---|---|---|---|
|
PK: Cmax of Evacetrapib (Fasted and Fed)
|
1100 ng/ml
Geometric Coefficient of Variation 57
|
1450 ng/ml
Geometric Coefficient of Variation 21
|
1090 ng/ml
Geometric Coefficient of Variation 44
|
1480 ng/ml
Geometric Coefficient of Variation 27
|
Adverse Events
130 mg Tablet Evacetrapib (Fasted)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 x 65 mg Tablets Evacetrapib (Fasted)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
130 mg Tablet Evacetrapib (Fed)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 x 65 mg Tablets Evacetrapib (Fed)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
130 mg Tablet Evacetrapib (Fasted)
n=48 participants at risk
Reference dose is a single oral dose of Reference one- 130 mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4.
|
2 x 65 mg Tablets Evacetrapib (Fasted)
n=48 participants at risk
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fasted state in Periods 1, 2, 3, and 4.
|
130 mg Tablet Evacetrapib (Fed)
n=23 participants at risk
Reference dose is a single oral dose of Reference one- 130 mg tablets of in fed state in Period 5.
|
2 x 65 mg Tablets Evacetrapib (Fed)
n=23 participants at risk
Test dose is a single oral dose of Test two- 65mg tablets of evacetrapib in fed state in Period 5.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
2.1%
1/48 • Number of events 1
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/23
The safety population includes all 48 participants who enrolled in the study.
|
8.7%
2/23 • Number of events 2
The safety population includes all 48 participants who enrolled in the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
2.1%
1/48 • Number of events 1
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/23
The safety population includes all 48 participants who enrolled in the study.
|
8.7%
2/23 • Number of events 2
The safety population includes all 48 participants who enrolled in the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
2.1%
1/48 • Number of events 1
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/23
The safety population includes all 48 participants who enrolled in the study.
|
8.7%
2/23 • Number of events 2
The safety population includes all 48 participants who enrolled in the study.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/23
The safety population includes all 48 participants who enrolled in the study.
|
8.7%
2/23 • Number of events 2
The safety population includes all 48 participants who enrolled in the study.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/23
The safety population includes all 48 participants who enrolled in the study.
|
8.7%
2/23 • Number of events 2
The safety population includes all 48 participants who enrolled in the study.
|
|
Investigations
White blood cell count increased
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/48
The safety population includes all 48 participants who enrolled in the study.
|
0.00%
0/23
The safety population includes all 48 participants who enrolled in the study.
|
8.7%
2/23 • Number of events 2
The safety population includes all 48 participants who enrolled in the study.
|
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