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Study of a Novel Subcutaneous Depot Formulation of Buprenorphine

NCT03715634 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-03-04

No results posted yet for this study

Summary

INDV-6200 is being developed for the treatment of opioid dependency and is expected to provide sustained buprenorphine plasma concentrations. The study will be done in healthy volunteers and will administer a non-therapeutic dose of INDV-6200. Study Period 1 will evaluate the oral tolerability of sublingual (SL) buprenorphine dosed over 3 days. Period 2 will administer the investigational medicinal product (IMP) or volume matched placebo.

Conditions

  • Opioid-use Disorder

Interventions

DRUG

INDV-6200

Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo

DRUG

Placebo

Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo

DRUG

SL Buprenorphine

All subjects will receive SL buprenorphine as non-investigational IMP to confirm tolerability

DRUG

Nalorex

Both Periods will include series of nalorex administrations to antagonize potential opioid effects from buprenorphine

Sponsors & Collaborators

  • Indivior Inc.

    lead INDUSTRY

Principal Investigators

  • Nand Singh · Quotient Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2018-06-07
Completion
2018-06-07

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03715634 on ClinicalTrials.gov