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

NCT04003402 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ASP8062

oral

DRUG

Alcohol

oral

DRUG

ASP8062 Placebo

oral

DRUG

Alcohol Placebo

oral

Sponsors & Collaborators

  • Astellas Pharma Global Development, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Global Development, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2019-10-16
Completion
2019-10-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04003402 on ClinicalTrials.gov