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Study to Assess Repeated Doses of INDV-2000 in Healthy Volunteers and in Treatment Seeking Individuals With Opioid Use Disorder

NCT04976855 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-08-21

Study results available
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Summary

The primary objectives for the study are:

* Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers.
* Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment seeking population.

Conditions

  • Healthy Volunteer
  • Opioid-use Disorder

Interventions

DRUG

INDV-2000

Capsule for oral administration

DRUG

Placebo

Capsule for oral administration

DRUG

SUBOXONE® sublingual film

Administered either under the tongue (sublingual) or between the gum and cheek (buccal)

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Indivior Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2023-07-05
Completion
2023-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04976855 on ClinicalTrials.gov