Infection, Human Immunodeficiency VirusPhase 1NCT02480881
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)
A Phase 1 study testing BMS-663068, Oral Contraceptive and Loestrin 1.5/30 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 2 sites in United States.
Trial summary
This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. 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-663068, Oral Contraceptive and Loestrin 1.5/30
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Jul 2015to 11 Jan 2016
- 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
- Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive
- Women of child bearing potential with intact ovarian function by medical history and history of regular menstrual cycles must have been on a stable regimen of combination oral contraceptives containing EE and progestin (28 day regimen) without evidence of breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1
Who cannot join
- Any significant acute or chronic medical illness
- Other protocol defined exclusion criteria could apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Miami, Florida, 33143
GSK Investigational Site
San Antonio, Texas, 78209
About this study
Official title: Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-663068, Oral Contraceptive, Loestrin 1.5/30
- 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-663068Drug
Investigational product
Oral ContraceptiveDrug
Subject's existing combination OC tablet containing EE and progestin
Loestrin 1.5/30Drug
Also called Junel, Microgestin 1.5/30
OC containing EE and norethindrone acetate (NEA)
| Study group | Role | What they receive |
|---|---|---|
| Single Sequence A, B, C, and D | Experimental | Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth. Receives: Drug: BMS-663068; Drug: Oral Contraceptive; Drug: Loestrin 1.5/30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter Cmax
Pharmacokinetic parameter includes:
maximal observed concentration (Cmax) for EE and NE.
Measured: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Pharmacokinetic parameter AUC TAU
Pharmacokinetic parameter includes:
area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.
Measured: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Secondary outcomes (6)
Clinical Safety as Measured by Adverse Event Monitoring.
Adverse event monitoring
Measured: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by the Collection of Vital Signs.
Vital signs assessments
Measured: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).
12-lead ECGs
Measured: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as measured by Physical Examination.
Physical examinations
Measured: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by Clinical Laboratory Evaluations.
clinical chemistry, hematology, and urinalysis.
Measured: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Pharmacokinetic Parameter
Pharmacokinetic parameter:
-time of maximum observed concentration (Tmax) for EE and NE.
Measured: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start7 Jul 2015
- Primary completion11 Jan 2016
- Study completion11 Jan 2016
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480881
- Sponsor's protocol ID
- 206279
- Other IDs
- AI438-019
- Status last verified
- Jul 2017
- First submitted
- 18 Jun 2015
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BMS-663068 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT02480881
- Acronym / sponsor ID
- 206279
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 11 Jan 2016 (actual)
- Study completion
- 11 Jan 2016 (actual)
- First posted
- 25 Jun 2015 (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.
This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Sequence A, B, C, and D | Experimental | Drug: BMS-663068, Drug: Oral Contraceptive, Drug: Loestrin 1.5/30Treatment A/Cycle 1: OC containing EE and progestin taken by mouth. Treatment B/Cycle 2: OC containing EE and progestin taken by mouth. Treatment C/Cycle 3: Loestrin 1.5/30 taken by mouth. Treatment D/Cycle 4: Loestrin 1.5/30 (alone) and Loestrin 1.5/30 with BMS-663068 taken by mouth. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive
- Women of child bearing potential with intact ovarian function by medical history and history of regular menstrual cycles must have been on a stable regimen of combination oral contraceptives containing EE and progestin (28 day regimen) without evidence of breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1
Key exclusion criteria (2 listed)
- Any significant acute or chronic medical illness
- Other protocol defined exclusion criteria could apply.
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-663068Investigational product | Drug | Single Sequence A, B, C, and D |
| Oral ContraceptiveSubject's existing combination OC tablet containing EE and progestin | Drug | Single Sequence A, B, C, and D |
| Loestrin 1.5/30Also: Junel, Microgestin 1.5/30OC containing EE and norethindrone acetate (NEA) | Drug | Single Sequence A, B, C, and D |
Primary outcome
Pharmacokinetic parameter Cmax
Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Pharmacokinetic parameter includes: maximal observed concentration (Cmax) for EE and NE.
Pharmacokinetic parameter AUC TAU
Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
Pharmacokinetic parameter includes: area under the concentration-time curve in one dosing interval (AUC(TAU)) for EE and NE.
6 secondary outcomes
Clinical Safety as Measured by Adverse Event Monitoring.
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by the Collection of Vital Signs.
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by the Collection of Electrocardiograms (ECGs).
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as measured by Physical Examination.
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Clinical Safety as Measured by Clinical Laboratory Evaluations.
Time frame: From Day 1 (Treatment A/Cycle 1) to Day 22 (Treament D/Cycle 4)
Pharmacokinetic Parameter
Time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4
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 27 Jul 2017.
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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.
GSK Clinical Trials study director
ViiV Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-663068, Oral Contraceptive and Loestrin 1.5/30 in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 2 sites in United States.
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 2 inclusion and 2 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pharmacokinetic parameter Cmax (time frame: From Day 21 of Treatment C/Cycle 3 to Day 21 of Treatment D/Cycle 4). The study lists 2 primary outcomes in all. 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 27 Jul 2017.