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

August 8, 2017 updated by: ViiV Healthcare

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Time Frame: Days 1 to 10
Days 1 to 10
AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Time Frame: Days 1 to 10
Days 1 to 10

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2016

Primary Completion (Actual)

June 29, 2016

Study Completion (Actual)

June 29, 2016

Study Registration Dates

First Submitted

January 6, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206216
  • AI438-068 (Other Identifier: Bristol-Myers Squibb)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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