Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Not yet recruiting
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: Other, Open Label, Single Group Assignment, Pharmacokinetics Study
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
Additional Information
Starting date: November 2009
Ending date: March 2010
Last updated: October 7, 2009
|
