NCT04448561

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

A Phase 1 Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Participants were screened for up to 28 days prior to first investigational product administration. Eligible participants were admitted to the clinical unit on day -1 and were residential for a single period of 17 days/16 nights. Participants were discharged from the clinical unit on day 16 on the condition that all required assessments had been performed and that there were no medical reasons for a longer stay in the clinical unit.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	ASP8082	oral
DRUG	morphine	oral
DRUG	Placebo	oral

Timeline

• Start date: 2020-06-30
• Primary completion: 2020-09-11
• Completion: 2020-09-11
• First posted: 2020-06-26
• Last updated: 2024-11-21
• Results posted: 2021-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study