A Study of Evacetrapib (LY2484595) in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Evacetrapib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01903434

14623

I1V-MC-EIAU (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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