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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-12

Study Completion Date

2016-06-29

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.

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Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Part 1 (BMS-663068+methadone)

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Methadone

Intervention Type DRUG

Methadone

Part 2 (BMS-663068+buprenorphine and norbuprene)

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

Group Type EXPERIMENTAL

BMS-663068

Intervention Type DRUG

BMS-663068

Buprenorphine and Norbuprenorphine

Intervention Type DRUG

Buprenorphine and Norbuprenorphine

Interventions

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BMS-663068

Intervention Type DRUG

Methadone

Intervention Type DRUG

Buprenorphine and Norbuprenorphine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No