Phase 1
Completed N=48
A Study of Evacetrapib in Healthy Japanese Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02226653 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted) — 14600; 14600 nanogram·hour/milliliter (ng·h/mL)
Summary
The purpose of this study is to determine if two different dosing strategies for evacetrapib will have essentially the same effect on the body. The study will also explore the effect of a low fat meal on how the body absorbs evacetrapib. This study will last at least 15 weeks, not including screening. Screening is required within 28 days prior to the date of first dosing.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted) |
14600; 14600 | — |
| PRIMARY PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted) |
1130; 1100 | — |
| SECONDARY PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed) |
3.75; 2.50; 3.50; 2.75 | — |
| SECONDARY PK: AUC(0-∞)of Evacetrapib (Fasted and Fed) |
14800; 18900; 14600; 18600 | — |
| SECONDARY PK: Cmax of Evacetrapib (Fasted and Fed) |
1100; 1450; 1090; 1480 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy Japanese, as determined by medical history and physical examination
- Have a body mass index (BMI) of 18.0 to 29.9 kg/m^2
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria
- 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
- Have an abnormal supine blood pressure as determined by the investigator
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Are women who are pregnant or lactating
- Have used or intend to use over-the-counter, prescription medications, or herbal medicine 14 days prior to enrollment and during the study
- Have donated blood of more than 400 mL in the last 12 weeks (males) or in the last 16 weeks (females), or any blood donation (including apheresis) within the last 4 weeks
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), or are unwilling to abide by alcohol restrictions
- Are participants who currently smoke more than 10 cigarettes per day or are unwilling to abide by smoking restrictions
Data sourced from ClinicalTrials.gov (NCT02226653). 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.