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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

Summary

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

Clinical Details

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

Eligibility

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.

Locations and Contacts

Local Institution, St. Laurent, Quebec H4R2N6, Canada

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

Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

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

Page last updated: August 23, 2015

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