Clinical Trials

MainTitle

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

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02666001

First received: January 6, 2016
Last updated: August 8, 2017
Last Verified: August 2017
History of Changes
Purpose

Purpose

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 Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-663068
Drug : Methadone
Drug : Buprenorphine and Norbuprenorphine
Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by ViiV Healthcare:

Primary Outcome Measures

  • Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2) [ Time Frame: Days 1 to 10 ]
  • AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2) [ Time Frame: Days 1 to 10 ]
Secondary Outcome Measures:
  • 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 ]

Enrollment: 32
Study Start Date: January 12, 2016
Study Completion Date: June 29, 2016
Primary Completion Date: June 29, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Part 1 (BMS-663068+methadone)
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
Drug: BMS-663068

BMS-663068

Drug: Methadone

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

BMS-663068

Drug: Buprenorphine and Norbuprenorphine

Buprenorphine and Norbuprenorphine

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02666001

Locations

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
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02666001   History of Changes  
Other Study ID Numbers: 206216  
  AI438-068  
Study First Received: January 6, 2016  
Last Updated: August 8, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Buprenorphine
Methadone

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.