Study of Combined Oral Contraceptive Effects in Female Subjects

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02157467
First received: June 2, 2014
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
HIV/AIDS
Drug: BMS-955176
Drug: Ortho Cyclen
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination [ Time Frame: Before dosing (0 hour) through 24 hours after administration on Days 21 and 49 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum progesterone measurements [ Time Frame: Day 14, 21, 35, and 42 ] [ Designated as safety issue: No ]
  • Trough blood samples collected for BMS-955716 [ Time Frame: Days 48, 49, 50 ] [ Designated as safety issue: No ]
  • Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. [ Time Frame: Two to three months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 22
Study Start Date: June 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: NGMN/EE + 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)

Drug: BMS-955176 Drug: Ortho Cyclen

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02157467

Contacts
Contact: Robert Feldman, MD clinical.trials@bms.com

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Principal Investigator: Robert A Feldman, MD MRA Clinical Research & Miami Research Associates
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02157467     History of Changes
Other Study ID Numbers: AI468-041
Study First Received: June 2, 2014
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Contraceptives, Oral, Combined
Moxifloxacin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014