Clinical trial NCT00983957: Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-24
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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


Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Days 49 and 77
measure: Area Under the Concentration-Time Curve (AUC) in 1 Dosing Interval of Ethinyl Estradiol
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
measure: Time of Maximum Observed Plasma Concentration of Ethinyl Estradiol
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
measure: Maximum Observed Plasma Concentration of Norelgestromin
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
measure: Area Under the Concentration-Time Curve in 1 Dosing Interval of Norelgestromin
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
measure: Time of Maximum Observed Plasma Concentration of Norelgestromin
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
Secondary outcomes:
measure: Maximum Observed Plasma Concentration of Norgestrel
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
measure: Area Under the Concentration-Time Curve in 1 Dosing Interval of Norgestrel
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
measure: Time of Maximum Observed Plasma Concentration of Norgestrel
timeFrame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 h post-dose on Days 49 and 77
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
timeFrame: For AEs from start of treatment (Day 1) up to Day 78 or discharge and for SAEs from Day 1 to 30 days after last dose of study drug
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: From start of treatment (Day 1) up to Day 78 or discharge
measure: Number of Participants Demonstrating a Clinically Meaningful Effect in Vital Signs
timeFrame: Baseline, Day 28, Day 29, Day 67, Day 68, Day 78, Day of discharge
measure: Number of Participants Demonstrating a Clinically Meaningful Effect in ECG Parameters
timeFrame: Screening, Day 1, Day 67, Day 77
Other outcomes:
Locations:
city: Tempe
country: United States
facility: MDS Pharma Services (US), Inc
state: Arizona
city: Austin
country: United States
facility: Covance Clinical Research Unit, Inc.
state: Texas
city: St. Laurent
country: Canada
facility: Local Institution
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: