Drug Interaction Oral Contraceptive Pill (OCP)

Bristol-Myers Squibb20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus

Interventions

Ortho Tri-Cyclen®DRUG

Tablets, Oral, 1 Tablet, once daily

BMS-650032DRUG

Tablets, Oral, 600 mg, BID

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pra International

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

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

Time frame: 24 hours of dosing

Secondary Outcomes

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

Time frame: Safety will be assessed through day 78

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

Time frame: PK assessments will be done on Day 49, 50, 77 and 78

Data from ClinicalTrials.gov

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