At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating INDV-2000, Placebo, and 1 other intervention for Healthy Volunteer and Opioid-use Disorder. Completed, enrolled 64 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
Capsule for oral administration
Capsule for oral administration
Administered either under the tongue (sublingual) or between the gum and cheek (buccal)