Phase 1
Completed N=34
A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02365558 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib — 748; 959 nanograms per milliliter (ng/mL)
Summary
The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.
There are two parts to the study. Participation in both parts will be required.
The study will last approximately 30 days, not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib |
748; 959 | — |
| PRIMARY Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib |
3.00; 3.00 | — |
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) |
12400; 14100 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy participants, as determined by medical history and physical examination
- Females must be of non-child-bearing potential
- Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2)
Exclusion Criteria
- Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations
Data sourced from ClinicalTrials.gov (NCT02365558). 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.