Phase 1
Completed N=24
A Study of Evacetrapib in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01736254 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib — 1270; 1290 nanograms/milliliter (ng/mL)
Summary
The purpose of this study is to determine whether concentrations of the study drug (evacetrapib) in the blood stream is the same or is different when the person is also taking gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in combination. There is no washout period between doses. The safety of both of the study drugs given together will be evaluated. Information about any side effects that may have occurred will also be collected. This study will last approximately 36 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib |
1270; 1290 | — |
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib |
11300; 11400 | — |
| PRIMARY Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib |
4.00; 3.00 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil |
55700; 53800 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil |
17400; 16800 | — |
| SECONDARY Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Gemfibrozil |
1.00; 1.08 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy participants as determined by medical history and physical examination
- Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
Exclusion Criteria
- Have known allergies to evacetrapib and gemfibrozil, related compounds or any components of the formulation
- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Currently smoke cigarettes or use tobacco or nicotine substitutes
Data sourced from ClinicalTrials.gov (NCT01736254). 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.