A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
Phase 1
Completed
- Conditions
- Infection, Human Immunodeficiency Virus
- Interventions
- Registration Number
- NCT02666001
- Lead Sponsor
- ViiV Healthcare
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- 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
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Exclusion Criteria
- 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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 2 (BMS-663068+buprenorphine and norbuprene) Buprenorphine and Norbuprenorphine Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine Part 1 (BMS-663068+methadone) BMS-663068 Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone Part 1 (BMS-663068+methadone) Methadone Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone Part 2 (BMS-663068+buprenorphine and norbuprene) BMS-663068 Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
- Primary Outcome Measures
Name Time Method Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2) Days 1 to 10 AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2) Days 1 to 10
- Secondary Outcome Measures
Name Time Method Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation. For AEs, Days 1 to 10; for SAEs, Screening, Days 1 to 10 and up to 30 days post discontinuation of dosing
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Overland Park, Kansas, United States