Study of Combined Oral Contraceptive Effects in Female Subjects
Phase 1
Completed
- Conditions
- Infection, Human Immunodeficiency Virus
- Interventions
- Drug: Ortho Cyclen
- Registration Number
- NCT02157467
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 46
Inclusion Criteria
-
Signed Written Informed Consent a) The signed informed consent form
-
Target population
- a) Healthy female subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
- b) Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive, at screening and Day -1. BMI = weight (kg)/[height (m)]2
- c) Weight greater than or equal to 45 kg
- d) Subject Reenrollment: This study permits the reenrollment of a subject that has discontinued study as a pretreatment failure (ie, has not been treated). If reenrolled, the subject must be reconsented
-
Age and Reproductive Status
- a) Women, 18 to 40 years of age, inclusive
- b) Women of childbearing potential (WOCBP) with intact ovarian function as determined by medical history and history of regular menstrual cycles, and who have been on a stable regimen of Ortho Cyclen for at least 2 consecutive months without evidence of breakthrough bleeding or spotting, or subjects who have been using a stable regimen of another combination oral contraceptive containing EE for at least two months prior to dosing on Day 1 of Cycle 1 and willing to switch to Ortho Cyclen for the total duration of the study (approximately 78 days)
- c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to dosing on Day 1 of Cycle 1
- d) Women must not be breastfeeding
Exclusion Criteria
Medical History and Concurrent Diseases
- a) Any significant acute or chronic medical illness
- b) History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
- c) Current or recent (within 3 months of dosing on Day 1 of Cycle 1) gastrointestinal disease
- d) Any major surgery within 4 weeks of dosing on Day 1 of Cycle 1
- e) Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
- f) Donation of > 400 mL to a blood bank or in a clinical study (except a screening visit) within 8 weeks of dosing on Day 1 of Cycle 1
- g) Blood transfusion within 4 weeks of dosing on Day 1 of Cycle 1
- h) Inability to tolerate oral medication
- i) Inability to be venipunctured and/or tolerate venous access
- j) Smokers (those who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1 of Cycle 1)
- k) Recent (within 6 months of dosing on Day 1 of Cycle 1) drug or alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM IV), Diagnostic Criteria for Drug and Alcohol Abuse
- l) Any other sound medical, psychiatric, and/or social reason as determined by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: NGMN/EE + BMS-955176 Ortho Cyclen Cycle 1- Active Ortho Cyclen QD on Days 1 to 21. Inert Ortho Cyclen tablets on Days 22 to 28 Cycle 2- Active Ortho Cyclen QD alone on Days 29 to 39 (11 days), followed by concomitant administration of active Ortho Cyclen QD + BMS-955176 80 mg QD on Days 40 to 49 (10 days) Arm 1: NGMN/EE + BMS-955176 BMS-955176 Cycle 1- Active Ortho Cyclen QD on Days 1 to 21. Inert Ortho Cyclen tablets on Days 22 to 28 Cycle 2- Active Ortho Cyclen QD alone on Days 29 to 39 (11 days), followed by concomitant administration of active Ortho Cyclen QD + BMS-955176 80 mg QD on Days 40 to 49 (10 days)
- Primary Outcome Measures
Name Time Method Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination Before dosing (0 hour) through 24 hours after administration on Days 21 and 49
- Secondary Outcome Measures
Name Time Method Serum progesterone measurements Day 14, 21, 35, and 42 Trough blood samples collected for BMS-955716 Days 48, 49, 50 Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. Two to three months