A Study of Evacetrapib in Healthy Female Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:10/10/2018
Start Date:December 2012
End Date:May 2013

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Trial Summary
Trial Overview
Inclusion Criteria

Effects of Evacetrapib (LY2484595) on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Subjects

The purpose of this study is to evaluate the effects of evacetrapib on oral contraceptives
(Ortho-Cyclen®) when given to healthy female participants. The amount of female hormones
found in the blood will be measured and compared when taken alone and when taken with
evaceptrapib. Each woman will participate in two study periods. Information about any side
effects that may occur will also be collected.


Inclusion Criteria:

- Are pre-menopausal females, and who are healthy as determined by medical history and
physical examination

- Have a body mass index of 18 to 30 kilograms per square meter (kg/m^2)

Exclusion Criteria:

- Have known allergies to evacetrapib and Ortho-Cyclen (ethinyl estradiol and
norgestimate), related compounds or any components of the formulation

- Have a clinically significant 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

- Have taken injectable contraceptives within 12 months prior to the first dose of the
lead-in period or topical controlled delivery contraceptives (patch) for 3 months
prior to the first dose of the lead-in period

- Use of any tobacco- or nicotine-containing products within 6 months prior to the
lead-in phase and during the study
We found this trial at
1
site
Clinical Trial Facility in Dallas Texas
Dallas, Texas 75390
?
mi
from
Dallas, TX
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