Status:
COMPLETED
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00983957
Start Date
October 1 2009
End Date
February 1 2010
Last Update
October 16 2015
Active Locations (3)
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1
MDS Pharma Services (US), Inc
Tempe, Arizona, United States, 85283
2
Covance Clinical Research Unit, Inc.
Austin, Texas, United States, 78752
3
Local Institution
Saint-Laurent, Quebec, Canada, H4R2N6