Infection, Human Immunodeficiency Virus
Conditions
Brief summary
The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.
Interventions
DRUGBMS-955176
DRUGOrtho Cyclen
Sponsors
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Serum progesterone measurements | Day 14, 21, 35, and 42 |
Outcome results
None listed