A Study of Evacetrapib in Healthy Female Participants

Phase 1

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ortho-Cyclen	Ortho-Cyclen	Ortho-Cyclen (35 microgram (mcg) ethinyl estradiol and 250 mcg norgestimate) administered orally, once daily (QD), for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) in one of two treatment periods. Treatment A
Ortho-Cyclen + Evacetrapib	Evacetrapib	Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods. Treatment B
Ortho-Cyclen + Evacetrapib	Ortho-Cyclen	Ortho-Cyclen administered orally, QD, for 28 days (lead-in period). Then, Ortho-Cyclen orally QD for 28 Days (Days 1 to 28) and 130 mg evacetrapib orally, QD, for 21 days (Days 1 to 21) in one of two treatment periods. Treatment B

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Maximum Concentration (Cmax) of Norelgestromin	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin	Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

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.
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Dallas, Texas, United States