Study of Combined Oral Contraceptive Effects in Female Subjects

NCT02157467 | Completed Phase 1

• 2 other identifiers: 206293AI468-041
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

Arm 1: NGMN/EE + BMS-955176

EXPERIMENTAL

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

Interventions

BMS-955176 DRUG

Arm 1: NGMN/EE + BMS-955176

Ortho Cyclen DRUG

Arm 1: NGMN/EE + BMS-955176

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

BMS-955176; Moxifloxacin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Viiv Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 6, 2014
• Study Start: June 2, 2014
• Primary Completion: August 25, 2014
• Study Completion: August 25, 2014
• Last Updated: April 17, 2018

Record last verified: 2018-04