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

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ClinicalTrials.gov Identifier: NCT02666001
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : August 9, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: BMS-663068 Drug: Methadone Drug: Buprenorphine and Norbuprenorphine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068
Actual Study Start Date : January 12, 2016
Actual Primary Completion Date : June 29, 2016
Actual Study Completion Date : June 29, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Part 1 (BMS-663068+methadone)
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
Drug: BMS-663068

Drug: Methadone

Experimental: Part 2 (BMS-663068+buprenorphine and norbuprene)
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
Drug: BMS-663068

Drug: Buprenorphine and Norbuprenorphine
Buprenorphine and Norbuprenorphine

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666001

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United States, Florida
GSK Investigational Site
Orlando, Florida, United States, 32809
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
ViiV Healthcare
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Study Director: GSK Clinical Trials ViiV Healthcare
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02666001    
Other Study ID Numbers: 206216
AI438-068 ( Other Identifier: Bristol-Myers Squibb )
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents