Phase 1
Completed N=40
Study of Food on Evacetrapib (LY2484595) in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01810432 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib — 1140; 1720 nanograms/milliliter (ng/mL)
Summary
The purpose of this study is to measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.
The study has 2 periods. In each period, participants will take the study drug for 10 days, either with or without a meal. There is a minimum 14-day washout between each period.
This study is approximately 50 days, not including screening. Screening is required within 28 days prior to the start of the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib |
1140; 1720 | — |
| PRIMARY PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib |
9930; 14400 | — |
| PRIMARY PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib |
3.00; 3.00 | — |
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/m²)
- Are able to eat a high fat breakfast and abide by the food restrictions throughout the study
Exclusion Criteria
- Have known allergies to evacetrapib, 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
- Are participants who currently smoke cigarettes or use tobacco or nicotine substitutes
Data sourced from ClinicalTrials.gov (NCT01810432). 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.