Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen� in Healthy Female Subjects

Condition(s) targeted: Chronic Hepatitis C

Intervention: BMS-790052 (Drug); Ortho Tri-Cyclen® (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

The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.

Official title: The Effect of the Co-administration of BMS-790052 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri-Cyclen®) in Healthy Female Subjects

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

Primary outcome: Pharmacokinetic parameters AUC(TAU), Cmax

Secondary outcome: To assess the safety and tolerability of BMS-790052 and Ortho Tri-Cyclen® when co-administered

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

Criteria:

Inclusion Criteria:

- Healthy female subjects, 18-45 years, BMI 18-32 kg/m².

- Must be using an adequate method of contraception to avoid pregnancy throughout the

study. Exclusion Criteria:

- Abnormal Pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3

months prior to enrollment.

- Any significant or chronic uncontrolled medical illness.

Local Institution, St. Laurent, Quebec H4R2N6, Canada

Covance Clinical Research Unit, Inc., Austin, Texas 78752, United States

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Starting date: October 2009
Last updated: March 4, 2015