Drug Interaction Oral Contraceptive Pill (OCP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01063023
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : January 25, 2011
Information provided by:
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: Ortho Tri-Cyclen® Drug: BMS-650032 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm A - Ortho Tri-Cyclen®
1 to 28 days
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
Active Comparator: Arm B - Ortho Tri-Cyclen®
29 to 56 days
Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
Active Comparator: Arm C - Ortho Tri-Cyclen® + BMS-650032

Ortho Tri-Cyclen®: 57 to 77 days

BMS-650032: 68 to 77 days

Drug: Ortho Tri-Cyclen®
Tablets, Oral, 1 Tablet, once daily
Drug: BMS-650032
Tablets, Oral, 600 mg, BID

Primary Outcome Measures :
  1. Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU) [ Time Frame: 24 hours of dosing ]

Secondary Outcome Measures :
  1. To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered [ Time Frame: Safety will be assessed through day 78 ]
  2. 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 ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01063023

United States, Kansas
Pra International
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT01063023     History of Changes
Other Study ID Numbers: AI447-019
First Posted: February 5, 2010    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: June 2010

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors