A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers

Condition(s) targeted: HIV/AIDS

Intervention: BMS-663068 (Drug); Oral Contraceptive (Drug); Loestrin 1.5/30 (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Bristol-Myers Squibb

Overall contact:
Call Center, Phone: 210-225-5437

This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).

Official title: Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Pharmacokinetic Parameter

Pharmacokinetic Parameter

Secondary outcome:

Clinical Safety as Measured by Adverse Event Monitoring.

Clinical Safety as Measured by the Collection of Vital Signs.

Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).

Clinical Safety as measured by Physical Examination.

Clinical Safety as Measured by Clinical Laboratory Evaluations.

Pharmacokinetic Parameter

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass

index of 18. 0 kg/m2 to 32. 0 kg/m2, inclusive

- Women of child bearing potential with intact ovarian function by medical history and

history of regular menstrual cycles must have been on a stable regimen of combination oral contraceptives containing EE and progestin (28 day regimen) without evidence of

breakthrough bleeding or spotting for at least 2 consecutive months prior to Day - 1

Exclusion Criteria:

- Any significant acute or chronic medical illness

Other protocol defined exclusion criteria could apply.

Call Center, Phone: 210-225-5437

Miami Research Associates, Miami, Florida 33143, United States; Recruiting
Call Center, Phone: 305-722-0970
Martha Hernandez, MD, Principal Investigator

ICON Early Phase Services, LLC (formerly named Healthcare Discoveries, LLC), San Antonio, Texas 78209, United States; Recruiting
Call Center, Phone: 210-225-5437
Emanuel DeNoia, MD, Principal Investigator

Starting date: July 2015
Last updated: July 10, 2015