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

Phase 1
Completed
Conditions
Infection, Human Immunodeficiency Virus
Interventions
Registration Number
NCT02666001
Lead Sponsor
ViiV Healthcare
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Part 2 (BMS-663068+buprenorphine and norbuprene)Buprenorphine and NorbuprenorphineEffect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
Part 1 (BMS-663068+methadone)BMS-663068Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
Part 1 (BMS-663068+methadone)MethadoneEffect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
Part 2 (BMS-663068+buprenorphine and norbuprene)BMS-663068Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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

Trial Locations

Locations (1)

GSK Investigational Site

🇺🇸

Overland Park, Kansas, United States

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