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

This study has been completed.

First Received on September 23, 2009. Last Updated on January 24, 2011 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00983957

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 I

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Estradiol Ethinyl estradiol Norgestimate Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

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

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

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
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

Flaviviridae Infections
Contraceptives, Oral
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral, Combined
Moxifloxacin
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012