← Back to Search

Other

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

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 16
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, ASP0367, on people with mild to moderate liver problems and healthy individuals. Participants will take the drug, and researchers will monitor their blood and urine to see how the drug is processed and if there are any side effects.

Eligible Conditions
  • Liver disease
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pharmacokinetics (PK) of ASP0367 in Plasma: Area Under Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast)
Pharmacokinetics (PK) of ASP0367 in Plasma: Area Under The Concentration-time Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf)
Pharmacokinetics (PK) of ASP0367 in Plasma: Maximum Concentration (Cmax)
Secondary study objectives
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or AEs
Number of Participants with Adverse Events (AEs)
Number of Participants with Laboratory Value Abnormalities and/or AEs
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: ASP0367: Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants with normal hepatic function will receive a single dose of ASP0367 under fasting conditions on day 1.
Group II: ASP0367: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.
Group III: ASP0367: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Participants with mild hepatic impairment will receive a single dose of ASP0367 under fasting conditions on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bocidelpar
2021
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
200 Previous Clinical Trials
122,356 Total Patients Enrolled
Senior Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
54 Previous Clinical Trials
12,721 Total Patients Enrolled
~6 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top