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Completed

NCT Number: NCT02666001

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

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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Key information

Conditions

Infection, Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • 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
  • Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive
  • Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test and must not be breastfeeding
  • Men and WOCBP must agree to follow instructions for contraception

Exclusion criteria

  • History of any chronic or acute illness, gastrointestinal disease, smoking and alcohol abuse
  • Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that could affect its absorption
  • 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.
  • History of allergy to any drugs, BMS-663068, HIV attachment inhibitors, or related compounds

Treatment and study plan

BMS-663068

Drug

BMS-663068

Methadone

Drug

Methadone

Buprenorphine and Norbuprenorphine

Drug

Buprenorphine and Norbuprenorphine

Primary outcomes

  1. Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)

    Time frame: Days 1 to 10

  2. AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)

    Time frame: Days 1 to 10

Secondary outcomes

  1. Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.

    Time frame: For AEs, Days 1 to 10; for SAEs, Screening, Days 1 to 10 and up to 30 days post discontinuation of dosing

Sponsors and collaborators

Lead sponsor

ViiV Healthcare

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2016
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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