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Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00983957
First received: September 23, 2009
Last updated: January 24, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.


Condition Intervention Phase
Chronic Hepatitis C
Drug: BMS-790052
Drug: Ortho Tri-Cyclen®
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Pharmacokinetic parameters AUC(TAU), Cmax [ Time Frame: Within 24 hrs of Dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety and tolerability of BMS-790052 and Ortho Tri-Cyclen® when co-administered [ Time Frame: 78 days ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-790052 plus Ortho Tri-Cyclen® Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 10 days
Drug: Ortho Tri-Cyclen®
Tablets, Oral, once daily, 78 days

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00983957

Locations
United States, Texas
Covance Clinical Research Unit, Inc.
Austin, Texas, United States, 78752
Canada, Quebec
Local Institution
St. Laurent, Quebec, Canada, H4R2N6
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: NCT00983957     History of Changes
Other Study ID Numbers: AI444-020
Study First Received: September 23, 2009
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014