Tavapadon for Liver Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Liver Institute American Research Corporation, San Antonio, TX
Liver Diseases+1 More
Tavapadon - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

The primary purpose of the study is to assess the effect of hepatic impairment on the PK of tavapadon following administration of a single oral dose in participants with mild and moderate hepatic impairment relative to age, body weight, and sex-matched participants with normal hepatic function.

Eligible Conditions

  • Liver Diseases
  • Hepatic Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Liver Diseases

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Day 1 up to Follow-up (Day 15)

Day 15
Number of Participants with Adverse Events (AEs) and AEs by Severity
Number of Participants with Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG) Values
Number of Participants with Clinically Significant Abnormalities in Laboratory Values
Number of Participants with Clinically Significant Abnormalities in Physical and Neurological Examination Results
Number of Participants with Clinically Significant Abnormalities in Vital Sign Values
Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Tavapadon
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Tavapadon
Maximum Observed Plasma Concentration (Cmax) of Tavapadon

Trial Safety

Safety Progress

1 of 3

Other trials for Liver Diseases

Trial Design

3 Treatment Groups

Normal Hepatic Function
1 of 3
Mild Hepatic Function
1 of 3
Moderate Hepatic Function
1 of 3
Experimental Treatment

30 Total Participants · 3 Treatment Groups

Primary Treatment: Tavapadon · No Placebo Group · Phase 1

Normal Hepatic Function
Drug
Experimental Group · 1 Intervention: Tavapadon · Intervention Types: Drug
Mild Hepatic Function
Drug
Experimental Group · 1 Intervention: Tavapadon · Intervention Types: Drug
Moderate Hepatic Function
Drug
Experimental Group · 1 Intervention: Tavapadon · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 up to follow-up (day 15)
Closest Location: Texas Liver Institute American Research Corporation · San Antonio, TX
Photo of San Antonio  1Photo of San Antonio  2Photo of San Antonio  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Liver Diseases
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a score of at least 9 points on the Child-Pugh score.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.