NCT04003402

A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects

A Phase 1 Randomized, Placebo-controlled, Crossover Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the potential for pharmacokinetic (PK) and pharmacodynamics (PD) interactions between ASP8062 and alcohol. This study will also assess safety and tolerability of a single dose of ASP8062 with or without alcohol.

Detailed description

Participants will be admitted to the clinical unit on day -1 of each period and will be residential for 6 days/5 nights. Participants will be discharged from the clinical unit on day 5 of each period on the condition that all required assessments have been performed and that there are no medical reasons for a longer stay in the clinical unit. Participants will return to the clinical unit on days 7 and 10 for pharmacokinetic blood sampling.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ASP8062	oral
DRUG	Alcohol	oral
DRUG	ASP8062 Placebo	oral
DRUG	Alcohol Placebo	oral

Timeline

• Start date: 2019-07-16
• Primary completion: 2019-10-16
• Completion: 2019-10-16
• First posted: 2019-07-01
• Last updated: 2024-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study