Back to resultsA Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-663068
Methadone
Buprenorphine and Norbuprenorphine
Sponsored by
About this trial
This is an interventional other trial for Infection, Human Immunodeficiency Virus
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part 1 (BMS-663068+methadone)
Part 2 (BMS-663068+buprenorphine and norbuprene)
Arm Description
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
Outcomes
Primary Outcome Measures
Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Secondary Outcome Measures
Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
Full Information
NCT ID
NCT02666001
First Posted
January 6, 2016
Last Updated
August 8, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02666001
Brief Title
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
Official Title
A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 12, 2016 (Actual)
Primary Completion Date
June 29, 2016 (Actual)
Study Completion Date
June 29, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1 (BMS-663068+methadone)
Arm Type
Experimental
Arm Description
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone
Arm Title
Part 2 (BMS-663068+buprenorphine and norbuprene)
Arm Type
Experimental
Arm Description
Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
BMS-663068
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Methadone
Intervention Type
Drug
Intervention Name(s)
Buprenorphine and Norbuprenorphine
Intervention Description
Buprenorphine and Norbuprenorphine
Primary Outcome Measure Information:
Title
Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Time Frame
Days 1 to 10
Title
AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)
Time Frame
Days 1 to 10
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
GSK Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone
We'll reach out to this number within 24 hrs