Study of Combined Oral Contraceptive Effects in Female Subjects
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
BMS-955176
Ortho Cyclen
Sponsored by
About this trial
This is an interventional basic science trial for Infection, Human Immunodeficiency Virus
Eligibility Criteria
Inclusion Criteria:
- 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1: NGMN/EE + BMS-955176
Arm Description
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)
Outcomes
Primary Outcome Measures
Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination
Secondary Outcome Measures
Serum progesterone measurements
Trough blood samples collected for BMS-955716
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Full Information
NCT ID
NCT02157467
First Posted
June 2, 2014
Last Updated
April 13, 2018
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02157467
Brief Title
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
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2, 2014 (Actual)
Primary Completion Date
August 25, 2014 (Actual)
Study Completion Date
August 25, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: NGMN/EE + BMS-955176
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
BMS-955176
Intervention Type
Drug
Intervention Name(s)
Ortho Cyclen
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Serum progesterone measurements
Time Frame
Day 14, 21, 35, and 42
Title
Trough blood samples collected for BMS-955716
Time Frame
Days 48, 49, 50
Title
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Time Frame
Two to three months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viiv Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study of Combined Oral Contraceptive Effects in Female Subjects
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