Clinical trial NCT02157467: Study of Combined Oral Contraceptive Effects in Female Subjects
Official title: The Effect of Coadministration of BMS-955176 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection, Human Immunodeficiency Virus
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2014-06-06
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination
timeFrame: Before dosing (0 hour) through 24 hours after administration on Days 21 and 49
Secondary outcomes:
measure: Serum progesterone measurements
timeFrame: Day 14, 21, 35, and 42
measure: Trough blood samples collected for BMS-955716
timeFrame: Days 48, 49, 50
measure: Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
timeFrame: Two to three months
Other outcomes:
Locations:
Study officials:
affiliation: ViiV Healthcare
name: Viiv Clinical Trials
role: STUDY_DIRECTOR
References: