Phase 1
Completed N=24
A Study of Evacetrapib in Japanese and Non-Japanese Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01958489 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin — 142; 128 nanograms/milliliter (ng/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin |
142; 128 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin |
257; 229 | — |
| PRIMARY PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin |
1.00; 0.75 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01958489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.