Trial Outcomes & Findings for A Study of Evacetrapib in Japanese and Non-Japanese Participants (NCT NCT01958489)
NCT ID: NCT01958489
Last Updated: 2018-10-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
Results posted on
2018-10-09
Participant Flow
All participants were administered 40 milligrams (mg) Pravastatin on Day 1 (Period 1) and 130 mg Evacetrapib on Days 2 through 11 and 40 mg Pravastatin coadministered on Day 11 (Period 2).
Participant milestones
| Measure |
Pravastatin
40 mg oral dose of pravastatin was administered on Day 1.
|
Evacetrapib + Pravastatin
130 mg oral dose of evacetrapib was administered once daily (QD) on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
|---|---|---|
|
Period 1
STARTED
|
24
|
0
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
24
|
0
|
|
Period 1
COMPLETED
|
24
|
0
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
0
|
24
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
0
|
24
|
|
Period 2
COMPLETED
|
0
|
23
|
|
Period 2
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Pravastatin
40 mg oral dose of pravastatin was administered on Day 1.
|
Evacetrapib + Pravastatin
130 mg oral dose of evacetrapib was administered once daily (QD) on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
|---|---|---|
|
Period 2
Adverse Event
|
0
|
1
|
Baseline Characteristics
A Study of Evacetrapib in Japanese and Non-Japanese Participants
Baseline characteristics by cohort
| Measure |
Pravastatin and Evacetrapib + Pravastatin
n=24 Participants
40 mg oral dose of pravastatin was administered on Day 1. One hundred and thirty (130) mg oral dose of evacetrapib was administered QD on Days 2 through 11 and 40 mg oral dose of pravastatin was co-administered on Day 11.
|
|---|---|
|
Age, Continuous
|
31.8 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 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
|
10 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
|
1 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 Kingdom
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdosePopulation: All participants who had evaluable Cmax results at the specific time points.
Outcome measures
| Measure |
Pravastatin (Period 1)
n=23 Participants
40 mg oral dose of pravastatin was administered on Day 1.
|
Evacetrapib + Pravastatin (Period 2)
n=23 Participants
130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin
|
142 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
128 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
PRIMARY outcome
Timeframe: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdosePopulation: All participants who had evaluable AUC(0-∞) at the specific time points.
Outcome measures
| Measure |
Pravastatin (Period 1)
n=23 Participants
40 mg oral dose of pravastatin was administered on Day 1.
|
Evacetrapib + Pravastatin (Period 2)
n=23 Participants
130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin
|
257 nanograms*hours/milliliters (ng*h/mL)
Geometric Coefficient of Variation 27
|
229 nanograms*hours/milliliters (ng*h/mL)
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdosePopulation: All enrolled participants with evaluable tmax results at the specific time points.
Outcome measures
| Measure |
Pravastatin (Period 1)
n=23 Participants
40 mg oral dose of pravastatin was administered on Day 1.
|
Evacetrapib + Pravastatin (Period 2)
n=23 Participants
130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
|---|---|---|
|
PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin
|
1.00 hours
Interval 0.5 to 2.0
|
0.75 hours
Interval 0.5 to 1.5
|
Adverse Events
40 mg Pravastatin Japanese
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
130 mg Evacetrapib Japanese
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
40 mg Pravastatin + 130 mg Evacetrapib Japanese
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
40 mg Pravastatin Non-Japanese
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
130 mg Evacetrapib Non-Japanese
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
40 mg Pravastatin + 130-mg Evacetrapib Non-Japanese
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
40 mg Pravastatin Japanese
n=10 participants at risk
40 mg oral dose of pravastatin was administered on Day 1.
|
130 mg Evacetrapib Japanese
n=10 participants at risk
130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
40 mg Pravastatin + 130 mg Evacetrapib Japanese
n=10 participants at risk
40 mg oral dose of pravastatin was administered on Day 1. 130 mg oral dose of evacetrapib was administered QD on Days 2 through11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
40 mg Pravastatin Non-Japanese
n=14 participants at risk
40 mg oral dose of pravastatin was administered on Day 1.
|
130 mg Evacetrapib Non-Japanese
n=14 participants at risk
130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
40 mg Pravastatin + 130-mg Evacetrapib Non-Japanese
n=13 participants at risk
40 mg oral dose of pravastatin was administered on Day 1. 130 mg oral dose of evacetrapib was administered QD on Days 2 through 11 and a 40 mg oral dose of pravastatin coadministered on Day 11.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Increased appetite
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
7.7%
1/13 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Headache
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10
|
20.0%
2/10 • Number of events 5
|
10.0%
1/10 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
7.1%
1/14 • Number of events 1
|
14.3%
2/14 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
14.3%
2/14 • Number of events 2
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10
|
20.0%
2/10 • Number of events 3
|
0.00%
0/10
|
21.4%
3/14 • Number of events 3
|
7.1%
1/14 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
14.3%
2/14 • Number of events 5
|
0.00%
0/14
|
0.00%
0/13
|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
20.0%
2/10 • Number of events 2
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/13
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
7.7%
1/13 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/10
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/13
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/10
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/13
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER