A Study of Evacetrapib (LY2484595) in Healthy Participants

Phase 1

Completed

Brief Summary: The purpose of this study is to measure and compare the amounts of the study drug evacetrapib found in the blood after taking two different formulations. The study has 3 periods. Participants will take each formulation by mouth at least once. A minimum of 14 days will pass between study drug doses. The safety and tolerability of the study drug will also be examined. Information about any side effects that may occur will also be collected. This study will last approximately 6 weeks.

Recruitment & Eligibility

Inclusion Criteria

Male participants who agree to use a reliable method of birth control and not donate sperm during the study and for 90 days after study completion
Female participants who are not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
Have a body mass index of 18 to 32 kilograms per square meter (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

Are currently enrolled in or have completed or discontinued within the last 30 days from a clinical trial involving an investigational product
Have known allergies to evacetrapib, related compounds or any components of the formulation, or history of significant allergic disease as determined by the investigator
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
Are women who are pregnant or lactating
Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements, herbal medicine) 14 days prior to enrollment and during the study
Have donated blood of more than 500 milliliters (mL) within the last month
Have an average weekly alcohol intake that exceeds 21 units per week (for males) and 14 units per week (for females) or are unwilling to stop alcohol consumption 48 hours prior to each dose and while resident at the Clinical Research Unit (CRU)
Currently smoke or use tobacco or nicotine products

Arm && Interventions

Group	Intervention	Description
Evacetrapib -- Solid Fraction Test	Evacetrapib	Single oral dose of 130 milligram (mg) evacetrapib tablet on Day 1 of up to 2 of 3 periods
Evacetrapib -- Solid Fraction Reference	Evacetrapib	Single oral dose of 130 mg evacetrapib tablet on Day 1 of up to 2 of 3 periods

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib (LY2484595)	Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period	The maximum observed drug concentration (Cmax) of evacetrapib is summarized for each solid fraction control (Reference and Test).
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (LY2484595)	Predose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose in each period	Evacetrapib exposure in terms of Area Under the Concentration Versus Time Curve from time 0 extrapolated to infinity (AUC\[0-∞\]) is summarized for each solid fraction control (Reference and Test).

Secondary Outcome Measures

Name	Time	Method

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.
🇺🇸
Evansville, Indiana, United States
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.
🇺🇸Evansville, Indiana, United States