Infection, Human Immunodeficiency VirusPhase 1NCT02666001
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
A Phase 1 study testing BMS-663068, Methadone and Buprenorphine and Norbuprenorphine in people with Infection, Human Immunodeficiency Virus, run by ViiV Healthcare at 2 sites in United States.
Trial summary
The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infection, Human Immunodeficiency Virus
- What is being tested?
- BMS-663068, Methadone and Buprenorphine and Norbuprenorphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jan 2016to 29 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent
- Target population: Subjects on methadone maintenance therapy (for inclusion in Part 1) or buprenorphine and norbuprenorphine maintenance therapy (for inclusion in Part 2), who have been reliably participating in an oral methadone or buprenorphine and norbuprenorphine program and who are on a stable dose for at least 30 days prior to study screening
- Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive
- Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test and must not be breastfeeding
- Men and WOCBP must agree to follow instructions for contraception
Who cannot join
- History of any chronic or acute illness, gastrointestinal disease, smoking and alcohol abuse
- Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that could affect its absorption
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- History of allergy to any drugs, BMS-663068, HIV attachment inhibitors, or related compounds
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Orlando, Florida, 32809
GSK Investigational Site
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068
The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine.
- Conditions
- Infection, Human Immunodeficiency Virus
- Being tested
- BMS-663068, Methadone, Buprenorphine and Norbuprenorphine
- 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
BMS-663068
MethadoneDrug
Methadone
Buprenorphine and NorbuprenorphineDrug
Buprenorphine and Norbuprenorphine
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (BMS-663068+methadone) | Experimental | Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone Receives: Drug: BMS-663068; Drug: Methadone |
| Part 2 (BMS-663068+buprenorphine and norbuprene) | Experimental | Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine Receives: Drug: BMS-663068; Drug: Buprenorphine and Norbuprenorphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Measured: Days 1 to 10
AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Measured: Days 1 to 10
Secondary outcomes (1)
Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Measured: For AEs, Days 1 to 10; for SAEs, Screening, Days 1 to 10 and up to 30 days post discontinuation of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start12 Jan 2016
- Primary completion29 Jun 2016
- Study completion29 Jun 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT02666001
- Sponsor's protocol ID
- 206216
- Other IDs
- AI438-068
- Status last verified
- Aug 2017
- First submitted
- 6 Jan 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068
- ClinicalTrials.gov ID
- NCT02666001
- Acronym / sponsor ID
- 206216
- Conditions
- Infection, Human Immunodeficiency Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 29 Jun 2016 (actual)
- Study completion
- 29 Jun 2016 (actual)
- First posted
- 28 Jan 2016 (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 study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (BMS-663068+methadone) | Experimental | Drug: BMS-663068, Drug: MethadoneEffect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone |
| Part 2 (BMS-663068+buprenorphine and norbuprene) | Experimental | Drug: BMS-663068, Drug: Buprenorphine and NorbuprenorphineEffect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- Target population: Subjects on methadone maintenance therapy (for inclusion in Part 1) or buprenorphine and norbuprenorphine maintenance therapy (for inclusion in Part 2), who have been reliably participating in an oral methadone or buprenorphine and norbuprenorphine program and who are on a stable dose for at least 30 days prior to study screening
- Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive
- Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test and must not be breastfeeding
- Men and WOCBP must agree to follow instructions for contraception
Key exclusion criteria (4 listed)
- History of any chronic or acute illness, gastrointestinal disease, smoking and alcohol abuse
- Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that could affect its absorption
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- History of allergy to any drugs, BMS-663068, HIV attachment inhibitors, or related compounds
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-663068BMS-663068 | Drug | Part 1 (BMS-663068+methadone), Part 2 (BMS-663068+buprenorphine and norbuprene) |
| MethadoneMethadone | Drug | Part 1 (BMS-663068+methadone) |
| Buprenorphine and NorbuprenorphineBuprenorphine and Norbuprenorphine | Drug | Part 2 (BMS-663068+buprenorphine and norbuprene) |
Primary outcome
Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Time frame: Days 1 to 10
AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Time frame: Days 1 to 10
1 secondary outcome
Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Time frame: For AEs, Days 1 to 10; for SAEs, Screening, Days 1 to 10 and up to 30 days post discontinuation of dosing
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 9 Aug 2017.
- Individual participant dataSharing planned: No
Related trials for Infection, Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
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, Methadone and Buprenorphine and Norbuprenorphine 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 5 inclusion and 4 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 9 Aug 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?
Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2) (time frame: Days 1 to 10). 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 9 Aug 2017.