CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
ASP8062 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04447287
NCT04447287Phase 1Completed
CompareCT.gov

Phase 1b Randomized, Placebo-controlled Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Subjects With Opioid Use Disorder

Astellas Pharma Global Development, Inc.·interventional·Posted Jun 25, 2020·Updated Nov 21, 2024

In Brief

A Phase 1 clinical trial evaluating ASP8062, Placebo ASP8062, and 1 other intervention for Opioid Use Disorder. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The primary purpose of this study was to assess the safety and tolerability of multiple doses of buprenorphine/naloxone alone and buprenorphine/naloxone in combination with a single dose of ASP8062. This study also assessed the potential for pharmacokinetic interaction between ASP8062 and buprenorphine/naloxone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJun 25, 2020
Enrollment StartJun 29, 2020
Primary CompletionNov 25, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.0 years ago

Interventions

ASP8062drug

Oral

Placebo ASP8062drug

Oral

buprenorphine/naloxonedrug

Sublingual