INDV-6001 Multiple-Dose Pharmacokinetic Study

About the trial

Sponsor

Indivior Inc.

Tested

INDV-6001 (drug), Suboxone (drug), Sublocade (drug)

Dates

Started 2024-09-17; completion 2026-01-21

Results posted

Not yet

This is a multicentre, open-label, multiple dose study of INDV-6001 in adult participants with moderate or severe OUD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). The current study will evaluate the pharmacokinetics (PK), safety, and tolerability of INDV-6001 following multiple doses in participants with OUD to select optimum dosing regimens for future studies. Prior to receiving INDV-6001, participants will be stabilised on 12-16 mg of transmucosal (TM) BUP (SUBOXONE®) or will transition from a 100-mg monthly maintenance dose of SC extended-release BUP (SUBLOCADE®). This study will also evaluate the use of alternative injection sites (thig…

From ClinicalTrials.gov, last updated 2026-03-16. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Indivior Inc. reported $5.2M in research payments for this study in 2025 (295 payments).

Products named: Sublocade, Exel 2-3ml Syr Only L-L/n-S, Suboxone, Surguard3

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.