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

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ViiV Healthcare

Status and phase

Completed
Phase 1

Conditions

Infection, Human Immunodeficiency Virus

Treatments

Drug: Methadone
Drug: Buprenorphine and Norbuprenorphine
Drug: BMS-663068

Study type

Interventional

Funder types

Industry

Identifiers

NCT02666001
206216
AI438-068 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

32 participants in 2 patient groups

Part 1 (BMS-663068+methadone)
Experimental group
Description:
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
Treatment:
Drug: BMS-663068
Drug: Methadone
Part 2 (BMS-663068+buprenorphine and norbuprene)
Experimental group
Description:
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
Treatment:
Drug: BMS-663068
Drug: Buprenorphine and Norbuprenorphine

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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