NCT04976855

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

A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be conducted in 3 parts: Part I: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 7 days of dosing with INDV-2000 in healthy volunteers. Part II: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 28 days of dosing with INDV-2000 in healthy volunteers. Part III: This part is an open-label study in OUD treatment seeking individuals.

Conditions

• Healthy Volunteer
• Opioid-use Disorder

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-08-17
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2021-07-26
• Last updated: 2024-08-21
• Results posted: 2024-08-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study