A Study of Evacetrapib in Healthy Female Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Ortho-Cyclen; Drug: Evacetrapib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01746732

14617

I1V-MC-EIAP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Ortho-Cyclen

Experimental group

Description:

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

Treatment:

Drug: Ortho-Cyclen

Ortho-Cyclen + Evacetrapib

Experimental group

Description:

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

Treatment:

Drug: Evacetrapib

Drug: Ortho-Cyclen