Drug Interaction Oral Contraceptive Pill (OCP)

Condition(s) targeted: Hepatitis C Virus

Intervention: Ortho Tri-Cyclen® (Drug); BMS-650032 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects

Official title: Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)

Secondary outcome:

To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered

To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination

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

Criteria:

Inclusion Criteria:

- Healthy Females, 18-40 years, BMI 18 - 32kg/m². Must use an acceptable method of

contraception to avoid pregnancy throughout the study and 8 weeks after last dose of study drug Exclusion Criteria:

- Abnormal pap smear within 1 year prior to day 1

- Any significant or chronic uncontrolled medical illness

Pra International, Lenexa, Kansas 66219, United States

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Starting date: January 2010
Last updated: January 24, 2011