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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: BMS-790052; Drug: Ortho Tri-Cyclen®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00983957

AI444-020

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

47 participants in 1 patient group

BMS-790052 plus Ortho Tri-Cyclen®

Experimental group

Treatment:

Drug: Ortho Tri-Cyclen®

Drug: BMS-790052