Infection, Human Immunodeficiency VirusPhase 1NCT02157467
Study of Combined Oral Contraceptive Effects in Female Subjects
A Phase 1 study testing BMS-955176 and Ortho Cyclen in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare.
Trial summary
The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- BMS-955176 and Ortho Cyclen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2014to 25 Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
About this study
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
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
- Being tested
- BMS-955176, Ortho Cyclen
- Medical subject headings
- Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-955176Drug
Ortho CyclenDrug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: BMS-955176; Drug: Ortho Cyclen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial blood samples for plasma Ethinyl Estradiol and Norelgestromin determination
Measured: Before dosing (0 hour) through 24 hours after administration on Days 21 and 49
Secondary outcomes (3)
Serum progesterone measurements
Measured: Day 14, 21, 35, and 42
Trough blood samples collected for BMS-955716
Measured: Days 48, 49, 50
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Measured: Two to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start2 Jun 2014
- Primary completion25 Aug 2014
- Study completion25 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Viiv Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157467
- Sponsor's protocol ID
- 206293
- Other IDs
- AI468-041
- Status last verified
- Apr 2018
- First submitted
- 2 Jun 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02157467
- Acronym / sponsor ID
- 206293
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 2 Jun 2014 (actual)
- Primary completion
- 25 Aug 2014 (actual)
- Study completion
- 25 Aug 2014 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of BMS-955176 on the pharmacokinetics of coadministered oral contraceptives.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: NGMN/EE + BMS-955176 | Experimental | Drug: BMS-955176, Drug: Ortho CyclenCycle 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) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Signed Written Informed Consent a) The signed informed consent form
- Target population
- Age and Reproductive Status
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-955176 | Drug | Arm 1: NGMN/EE + BMS-955176 |
| Ortho Cyclen | Drug | Arm 1: NGMN/EE + BMS-955176 |
Primary outcome
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
3 secondary outcomes
Serum progesterone measurements
Time frame: Day 14, 21, 35, and 42
Trough blood samples collected for BMS-955716
Time frame: Days 48, 49, 50
Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests.
Time frame: Two to three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viiv Clinical Trials study director
ViiV Healthcare
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-955176 and Ortho Cyclen in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.