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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02666001

Enrollment

Registered

2016-01-28

Start date

2016-01-12

Completion date

2016-06-29

Last updated

2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Human Immunodeficiency Virus

Brief summary

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.

Interventions

DRUGBMS-663068

BMS-663068

DRUGMethadone

Methadone

DRUGBuprenorphine and Norbuprenorphine

Buprenorphine and Norbuprenorphine

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026