A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
Overview
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.
Full Title of Study: “A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: June 29, 2016
Interventions
- Drug: BMS-663068
- BMS-663068
- Drug: Methadone
- Methadone
- Drug: Buprenorphine and Norbuprenorphine
- Buprenorphine and Norbuprenorphine
Arms, Groups and Cohorts
- Experimental: Part 1 (BMS-663068+methadone)
- Effect of multiple doses of BMS-663068, 600mg ER on the exposure of 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
Clinical Trial Outcome Measures
Primary Measures
- 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
Secondary Measures
- 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
Participating in This Clinical Trial
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:
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- ViiV Healthcare
- Collaborator
- GlaxoSmithKline
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- GSK Clinical Trials, Study Director, ViiV Healthcare
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