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CompletedNCT02666001Updated Aug 9, 2017

A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone

A Phase 1 interventional study of BMS-663068 and Methadone in Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-08-09.

Sponsored by ViiV Healthcare · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Infection, Human Immunodeficiency Virus
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In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 32 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.

Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed Informed Consent
  2. 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
  3. Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive
  4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test and must not be breastfeeding
  5. Men and WOCBP must agree to follow instructions for contraception

Exclusion criteria

Exclusion Criteria:

  1. History of any chronic or acute illness, gastrointestinal disease, smoking and alcohol abuse
  2. Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that could affect its absorption
  3. 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.
  4. History of allergy to any drugs, BMS-663068, HIV attachment inhibitors, or related compounds
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Part 1 (BMS-663068+methadone)

    Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone

    Drug: BMS-663068 · Drug: Methadone

  • Experimental
    Part 2 (BMS-663068+buprenorphine and norbuprene)

    Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine

    Drug: BMS-663068 · Drug: Buprenorphine and Norbuprenorphine

Interventions

  • DrugBMS-663068

    BMS-663068

  • DrugMethadone

    Methadone

  • DrugBuprenorphine and Norbuprenorphine

    Buprenorphine and Norbuprenorphine

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What researchers measure

Primary outcomes

  1. Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)

    Time frame: Days 1 to 10

  2. AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)

    Time frame: Days 1 to 10

Secondary outcomes

  1. 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

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Study locations

2 sites
  • GSK Investigational Site
    Orlando, Florida 32809, United States
  • GSK Investigational Site
    Overland Park, Kansas 66211, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02666001
Lead sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jan 28, 2016
Start date
Jan 12, 2016
Primary completion
Jun 29, 2016
Completion
Jun 29, 2016
Last update
Aug 9, 2017

Study contacts

GSK Clinical Trials
study director · ViiV Healthcare

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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