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NCT04003402 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Healthy Volunteers, sponsored by Astellas Pharma Global Development.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT04003402 is a Phase 1 study of Healthy Volunteers that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 20 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04003402, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Astellas Pharma Global Development.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DRUG Alcohol
  • DRUG ASP8062
  • DRUG ASP8062 Placebo
  • DRUG Alcohol Placebo

Study Locations (1)

Maryland

  • Parexel International - EPCU Baltimore - Baltimore

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2019-07-16
Est. Completion 2019-10-16
Phase Phase 1

Sponsor

Astellas Pharma Global Development

168 total trials

What the Registry Record Tells You About NCT04003402

The ClinicalTrials.gov registry entry for NCT04003402 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (96% lower). The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which Alcohol is the first listed.

NCT04003402 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04003402 about?

NCT04003402 is a clinical study titled "A Study to Assess Potential Interaction Between ASP8062 and Alcohol in Healthy Adult Subjects". 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.

What is the current status of trial NCT04003402?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-07-16. Estimated completion is 2019-10-16.

What conditions does trial NCT04003402 study?

This clinical trial studies the following conditions: Healthy Volunteers.

What interventions are being tested in trial NCT04003402?

The interventions under investigation include: Alcohol (DRUG), ASP8062 (DRUG), ASP8062 Placebo (DRUG), Alcohol Placebo (DRUG).

Who is sponsoring clinical trial NCT04003402?

This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04003402 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.