NCT02666001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

January 12, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2016

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

6 months

First QC Date

January 6, 2016

Last Update Submit

August 8, 2017

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (2)

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

    Days 1 to 10

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

    Days 1 to 10

Secondary Outcomes (1)

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

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

Study Arms (2)

Part 1 (BMS-663068+methadone)

EXPERIMENTAL

Effect of multiple doses of BMS-663068, 600mg ER on the exposure of methadone

Drug: BMS-663068Drug: Methadone

Part 2 (BMS-663068+buprenorphine and norbuprene)

EXPERIMENTAL

Effect of multiple doses of BMS-663068, 600mg ER on the exposure of buprenorphine and norbuprenorphine

Drug: BMS-663068Drug: Buprenorphine and Norbuprenorphine

Interventions

BMS-663068DRUG

BMS-663068

Part 1 (BMS-663068+methadone)Part 2 (BMS-663068+buprenorphine and norbuprene)
MethadoneDRUG

Methadone

Part 1 (BMS-663068+methadone)
Buprenorphine and NorbuprenorphineDRUG

Buprenorphine and Norbuprenorphine

Part 2 (BMS-663068+buprenorphine and norbuprene)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

GSK Investigational Site

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

InfectionsAcquired Immunodeficiency Syndrome

Interventions

fostemsavirMethadoneBuprenorphinenorbuprenorphine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • GSK Clinical Trials

    ViiV Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 28, 2016

Study Start

January 12, 2016

Primary Completion

June 29, 2016

Study Completion

June 29, 2016

Last Updated

August 9, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)