Drug Interaction Oral Contraceptive Pill (OCP)
Phase 1
Completed
- Conditions
- Hepatitis C Virus
- Interventions
- Drug: Ortho Tri-Cyclen®Drug: BMS-650032
- Registration Number
- NCT01063023
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 20
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
Read More
Exclusion Criteria
- Abnormal pap smear within 1 year prior to day 1
- Any significant or chronic uncontrolled medical illness
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A - Ortho Tri-Cyclen® Ortho Tri-Cyclen® 1 to 28 days Arm B - Ortho Tri-Cyclen® Ortho Tri-Cyclen® 29 to 56 days Arm C - Ortho Tri-Cyclen® + BMS-650032 Ortho Tri-Cyclen® Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days Arm C - Ortho Tri-Cyclen® + BMS-650032 BMS-650032 Ortho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days
- Primary Outcome Measures
Name Time Method Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU) 24 hours of dosing
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered Safety will be assessed through day 78 To characterize the PK of norgestrel when Ortho Tri-Cylen® is administered alone and in combination PK assessments will be done on Day 49, 50, 77 and 78
Trial Locations
- Locations (1)
Pra International
🇺🇸Lenexa, Kansas, United States