Study of Combined Oral Contraceptive Effects in Female Subjects

Infection, Human Immunodeficiency Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157467
• Other study ID #: 206293
• Secondary ID: AI468-041
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2014
• Last updated: April 13, 2018
• Start date: June 2, 2014
• Est. completion date: August 25, 2014

Study information

• Verified date: April 2018
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 25, 2014
• Est. primary completion date: August 25, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• BMS-955176

• Ortho Cyclen

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Serum progesterone measurements		Day 14, 21, 35, and 42
Secondary	Trough blood samples collected for BMS-955716		Days 48, 49, 50
Secondary	Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.		Two to three months