A Study of Evacetrapib in Healthy Japanese Participants

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Evacetrapib (reference)	Evacetrapib	Single oral dose of 1 tablet of evacetrapib on Day 1 of up to three of five periods
Evacetrapib (test)	Evacetrapib	Single oral dose of 2 tablets of evacetrapib on Day 1 of up to three of five periods

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (Fasted)	Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4
PK: Maximum Concentration (Cmax) of Evacetrapib (Fasted)	Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 1,2,3, and 4

Secondary Outcome Measures

Name	Time	Method
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib (Fasted and Fed)	Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5
PK: AUC(0-∞)of Evacetrapib (Fasted and Fed)	Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5
PK: Cmax of Evacetrapib (Fasted and Fed)	Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 Hours Post-dose in Periods 2,4, and 5

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Fukuoka, Japan