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Dopamine Agonist

Tavapadon for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Cerevel Therapeutics, LLC
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 day 1 up to follow-up (day 15)
Awards & highlights

Study Summary

This trial is testing how well a new drug works in people with different levels of liver impairment, compared to people with normal liver function.

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to follow-up (day 15)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to follow-up (day 15) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
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
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
Group II: Moderate Hepatic FunctionExperimental Treatment1 Intervention
Participants will receive a single dose of tavapadon, 0.5 milligrams (mg) or 0.25 mg tablet based on tolerability, on Day 1.
Group III: Mild Hepatic FunctionExperimental Treatment1 Intervention
Participants will receive a single dose of tavapadon, 0.5 mg or 0.25 mg tablet based on tolerability, on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tavapadon
2022
Completed Phase 1
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,683 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enrolled in this research endeavor?

"Affirmative. According to the information provided on clinicaltrials.gov, this trial is actively seeking applicants and was initially posted on April 29th 2022, with a recent update taking place in July 8th 2022. The study needs 30 volunteers from one medical centre."

Answered by AI

Do I qualify for participation in this clinical trial?

"This medical trial is recruiting thirty patients aged 18 to 75 with a BMI between 17.5 and 42 kg/m^2, body weight of more than 50 kilograms (110 lbs), Class A or B modified Child-Pugh classification, stable hepatic disease over the last 28 days preceding screening visit, previous alcohol abuse if willing to follow lifestyle guidelines and breath test negative at Screening and Check-in Day -1."

Answered by AI

How hazardous is it to take Tavapadon?

"With limited data supporting both safety and efficacy, Tavapadon was assigned a score of 1 on our scale for risk assessment."

Answered by AI

Is the current research recruiting participants?

"Affirmative. Per the data presented on clinicaltrials.gov, this research endeavour is still looking for participants since its initial posting on April 29th 2022 and last update on July 8th 2022. The team requires 30 volunteers from a single medical centre to complete their trial."

Answered by AI

Is eligibility for this trial restricted to individuals under 35 years old?

"The study necessitates that those enrolling are between 18 to 75 years old. Additionally, the trial offers 27 clinical studies for minors and 223 trials for seniors."

Answered by AI
~11 spots leftby Apr 2025