A Study of Evacetrapib in Healthy Female Participants

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Evacetrapib; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

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