Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non-Japanese Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin
Study Overview
Brief Summary
The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.
This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overtly healthy participants, as determined by medical history and physical examination
- •Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
- •Japanese participants must be first generation Japanese
Exclusion Criteria
- Not provided
Arms & Interventions
Pravastatin
Single 40 milligram (mg) oral dose of pravastatin administered on Day 1.
Intervention: Pravastatin (Drug)
Evacetrapib + Pravastatin
Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.
Intervention: Evacetrapib (Drug)
Evacetrapib + Pravastatin
Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.
Intervention: Pravastatin (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin
Time Frame: 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
PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin
Time Frame: 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
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported