A Study of Evacetrapib in Healthy Female Participants

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Ortho-Cyclen
* Drug: Evacetrapib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ortho-Cyclen<br>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 | Drug: Ortho-Cyclen<br>* Oral administration<br>|
| Experimental: Ortho-Cyclen + Evacetrapib<br>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 | Drug: Ortho-Cyclen<br>* Oral administration<br>Drug: Evacetrapib<br>* Oral administration<br>* Other names: LY2484595;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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: 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: 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 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 |