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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068

Conditions
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Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: BMS-663068
* Drug: Methadone
* Drug: Buprenorphine and Norbuprenorphine


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1 (BMS-663068+methadone)<br>Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone | Drug: BMS-663068<br>* BMS-663068<br>Drug: Methadone<br>* Methadone<br>|
| Experimental: Part 2 (BMS-663068+buprenorphine and norbuprene)<br>Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine | Drug: BMS-663068<br>* BMS-663068<br>Drug: Buprenorphine and Norbuprenorphine<br>* Buprenorphine and Norbuprenorphine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |