Phase 1
Completed N=26
A Study of Evacetrapib and Rifampin in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01908582 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib — 599; 269 nanograms per milliliter (ng/mL)
Summary
The main purpose of this study is to determine how much evacetrapib gets into the blood stream and how long it takes the body to get rid of it when given with rifampin. The safety and tolerability of the two drugs, given together, will also be evaluated. The study will also look at blood cholesterol levels and levels of a hormone called cortisol before and after taking rifampin. Information about any side effects that may occur will also be collected.
For each participant, this study will include 2 periods in fixed order. The study will last approximately 29 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib |
599; 269 | — |
| PRIMARY Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib |
2.00; 2.00 | — |
| PRIMARY Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib |
9810; 2070 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy males and females (of non child-bearing potential)
- Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2), inclusive, at screening
Exclusion Criteria
- Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT01908582). 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.