Drug Interaction Oral Contraceptive Pill (OCP)
Effect of BMS-650032 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate (Ortho Tri- Cyclen (R)) in Healthy Female Subjects
1 other identifier
interventional
20
1 country
1
Brief Summary
To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and norelgestromin (NGMN) in healthy female subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 3, 2010
CompletedFirst Posted
Study publicly available on registry
February 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 25, 2011
June 1, 2010
5 months
February 3, 2010
January 24, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)
24 hours of dosing
Secondary Outcomes (2)
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
Study Arms (3)
Arm A - Ortho Tri-Cyclen®
ACTIVE COMPARATOR1 to 28 days
Arm B - Ortho Tri-Cyclen®
ACTIVE COMPARATOR29 to 56 days
Arm C - Ortho Tri-Cyclen® + BMS-650032
ACTIVE COMPARATOROrtho Tri-Cyclen®: 57 to 77 days BMS-650032: 68 to 77 days
Interventions
Tablets, Oral, 1 Tablet, once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Abnormal pap smear within 1 year prior to day 1
- Any significant or chronic uncontrolled medical illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pra International
Lenexa, Kansas, 66219, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 3, 2010
First Posted
February 5, 2010
Study Start
January 1, 2010
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
January 25, 2011
Record last verified: 2010-06