A Study of Evacetrapib in Healthy Female Participants

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746732
• Other study ID #: 14617
• Secondary ID: I1V-MC-EIAP
• Status: Completed
• Phase: Phase 1
• Start date: December 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Ortho-Cyclen
Oral administration
• Evacetrapib
Oral administration

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCt) 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
Primary	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
Primary	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
Primary	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
Primary	PK: Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCt) of Norelgestromin		Day 21: Predose, 0.5,1,1.5,2,3,4,5,6,8,10,12,16 and 24 hours post dose
Primary	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
Primary	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