Study of Combined Oral Contraceptive Effects in Female Subjects

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: Infection, Human Immunodeficiency Virus

Treatments: Drug: BMS-955176; Drug: Ortho Cyclen

Study type: Interventional

Funder types: Industry

Identifiers

NCT02157467

AI468-041 (Other Identifier)

206293

Details and patient eligibility

About

The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.

Enrollment: 46 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed Written Informed Consent a) The signed informed consent form

2. 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

3. 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Arm 1: NGMN/EE + BMS-955176

Experimental group

Description:

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)

Treatment:

Drug: BMS-955176

Drug: Ortho Cyclen