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A Study to Evaluate ASP0367 in Participants with Mild/Moderate Hepatic Impairment Compared to Participants with Normal Hepatic Function

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT04942964

Astellas Study ID

The unique identification code given by the study sponsor.

0367-CL-1102

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Follow Trial

Condition

Liver Disease, Healthy Volunteer

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 Years - 75 Years

Sex

Female & Male

Product

ASP0367

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jul 2021 - Jan 2022

Masking

None (Open Label)

Enrollment number

25

A Phase 1 Open-label Study to Evaluate the Effect of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP0367 Compared to Participants with Normal Hepatic Function

Study summary

Get More Information

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Locations

Texas Liver Institute

San Antonio, United States, 78215

Advanced Pharma CR, LLC

Miami, United States, 33147

Orlando Clinical Research Center, Inc

Orlando, United States, 32809

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