Drug Interaction Oral Contraceptive Pill (OCP)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus

Treatments: Drug: Ortho Tri-Cyclen®; Drug: BMS-650032

Study type: Interventional

Funder types: Industry

Identifiers

NCT01063023

AI447-019

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

20 participants in 3 patient groups

Arm A - Ortho Tri-Cyclen®

Active Comparator group

Description:

1 to 28 days

Treatment:

Drug: Ortho Tri-Cyclen®

Arm B - Ortho Tri-Cyclen®

Active Comparator group

Description:

29 to 56 days

Treatment:

Drug: Ortho Tri-Cyclen®

Arm C - Ortho Tri-Cyclen® + BMS-650032

Active Comparator group

Description:

Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days

Treatment:

Drug: BMS-650032

Drug: Ortho Tri-Cyclen®