Drug Interaction Oral Contraceptive Pill (OCP)

Hepatitis C Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01063023
• Other study ID #: AI447-019
• Status: Completed
• Phase: Phase 1
• First received: February 3, 2010
• Last updated: January 24, 2011
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

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

Locations

Country	Name	City	State
United States	Pra International	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters for ethinyl estradiol (EE), norelgestromin (NGMN) and norgestrel (NG), AUC (TAU)		24 hours of dosing	No
Secondary	To assess the safety and tolerability of investigational drug and Ortho Tri-Cyclen® when administered		Safety will be assessed through day 78	Yes
Secondary	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	Yes

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form