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A Study of Evacetrapib in Healthy Female Participants

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Ortho-Cyclen (Drug); Evacetrapib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Norgestimate/Ethinyl Estradiol

Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCĎ„) of Norgestimate/Ethinyl Estradiol

Pharmacokinetics (PK): Minimum Observed Drug Concentration (Cmin) of Norgestimate/Ethinyl Estradiol

Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Norgestimate/Ethinyl Estradiol

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

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., Dallas, Texas 75247, United States
Additional Information

Starting date: December 2012
Last updated: June 18, 2013

Page last updated: August 23, 2015

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