A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Phase 1 Completed 23 enrolled Astellas Pharma Global Development, Inc. National Institute on Drug Abuse (NIDA) · collab

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-06-29
Primary completion: 2020-11-25
Completion: 2020-11-25

Publications

Ito M, Walzer M, Beth Blauwet M, Spence A, Heo N, Kelsh D, Blahunka P, Erdman J, Nour Alsharif M, Marek GJ. A phase 1b study to investigate the potential interactions between ASP8062 and buprenorphine/naloxone in patients with opioid use disorder. J Psychopharmacol. 2023 Feb;37(2):144-154. doi: 10.1177/02698811221149657. Epub 2023 Feb 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP8062	Unknown	60 mg	Oral
Background	Buprenorphine	Other / unclassified	16 mg	Other
Background	Naloxone	Small molecule	4 mg	Other

A Study to Assess the Effect of a Single Dose of ASP8062 on the Multiple Dose Safety, Tolerability and Pharmacokinetics of Buprenorphine/Naloxone in Participants With Opioid Use Disorder

Summary

Timeline

Publications

Drugs

Indications