Phase 1
Completed N=95
A Study of Different Particle Sizes of Evacetrapib in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02497391 ↗
Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib — 983; 1170; 1120 nangram/milliliter (ng/mL)
Summary
The purpose of this study is to determine if there is any difference in the way the body handles 3 types of evacetrapib tablets with different particle sizes. Information about any side effects will also be collected. This study will consist of 3 study periods. Participants will be dosed 3 times during the entire study. Each study period will consist of an inpatient stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks from first dose to end of study. Screening will take place within 28 days prior to the first dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib |
983; 1170; 1120 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib |
14700; 16100; 15500 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy participants of non-child bearing potential
- Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
- Must be willing to make oneself available for the whole study and be willing to follow study procedures
Exclusion Criteria
- Have known allergies to evacetrapib, compounds or components related to this drug, or have a history of significant allergic reactions of another origin.
Data sourced from ClinicalTrials.gov (NCT02497391). 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.