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

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