drugset
drugset / Trial / NCT04976855

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

NCT04976855 ↗

Phase 1 Completed 64 enrolled Indivior Inc. National Institute on Drug Abuse (NIDA) · collab
RandomizedSequentialDouble-blindTreatment

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.

Timeline

Start
2022-08-17
Primary completion
2023-07-05
Completion
2023-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject INDV-2000 Unknown 100 mg Oral
Subject INDV-2000 Unknown 200 mg Oral
Subject INDV-2000 Unknown 400 mg Oral
Background Buprenorphine Other / unclassified — Other

Indications

opiate dependence