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Completed

NCT Number: NCT01746732

A Study of Evacetrapib in Healthy Female Participants

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ortho-Cyclen

Drug

Oral administration

Evacetrapib

Drug

Oral administration

Other names: LY2484595

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ethinyl Estradiol

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

  2. PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Ethinyl Estradiol

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

  3. PK: Minimum Observed Drug Concentration (Cmin) of Ethinyl Estradiol

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

  4. PK: Time of Maximum Observed Drug Concentration (Tmax) of Ethinyl Estradiol

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

  5. PK: Maximum Concentration (Cmax) of Norelgestromin

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

  6. PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Norelgestromin

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

  7. PK: Minimum Observed Drug Concentration (Cmin) of Norelgestromin

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

  8. PK: Time of Maximum Observed Drug Concentration (Tmax) of Norelgestromin

    Time frame: Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2012
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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