Drug Interaction Oral Contraceptive Pill (OCP)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01063023
First received: February 3, 2010
Last updated: January 24, 2011
Last verified: June 2010
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU) [ Time Frame: 24 hours of dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered [ Time Frame: Safety will be assessed through day 78 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063023

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

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01063023     History of Changes
Other Study ID Numbers: AI447-019
Study First Received: February 3, 2010
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014