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Dopamine Agonist

Tavapadon for Kidney Failure

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 drug works in people with different levels of kidney function.

Eligible Conditions
  • Kidney Failure

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 Time 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

2Treatment groups
Experimental Treatment
Group I: Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants with severe renal impairment will receive a single dose of tavapadon, 0.25 milligrams (mg) tablet, on Day 1.
Group II: Normal Renal FunctionExperimental Treatment1 Intervention
Participants with normal renal function will receive a single dose of tavapadon, 0.25 mg tablet, 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
5,701 Total Patients Enrolled

Media Library

Tavapadon (Dopamine Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05404542 — Phase 1
Kidney Failure Research Study Groups: Severe Renal Impairment, Normal Renal Function
Kidney Failure Clinical Trial 2023: Tavapadon Highlights & Side Effects. Trial Name: NCT05404542 — Phase 1
Tavapadon (Dopamine Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05404542 — Phase 1

Frequently Asked Questions

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

To whom is eligibility for this research open?

"This research effort is seeking 20 participants, aged 18-80 and with deteriorating renal function. These prospective patients must also display the following characteristics: body mass index of at least 18 to 40 kg/m^2, total body weight higher than 50kg (110 lbs), age within a 10 year range from median for severe renal impairment cohort, bodyweight similar or up to 15kg more than median for severe renal impairment cohort, eGFR lower than 30mL per minute without requiring dialysis according to CKD-EPI equation, no clinically significant changes in health status documented by recent eGFR assessment within 3 months before screening process and"

Answered by AI

What is the aggregate of individuals participating in this trial?

"Affirmative. Clinicaltrials.gov verifies that this scientific investigation, which was first published on May 10th 2022, is actively enrolling participants. A total of 20 individuals are desired to take part in the study at a single site."

Answered by AI

Does this trial consider participants aged thirty or older?

"Per the stated inclusion criteria, individuals aged 18 and above are eligible for this clinical trial up to a maximum of 80 years old."

Answered by AI

Are there any enrollment opportunities for this clinical trial at present?

"Affirmative, according to the data hosted on clinicaltrials.gov this medical trial is currently recruiting participants. It was posted on May 10th 2022 and has been edited most recently on July 8th of the same year. They are looking for 20 individuals at 1 location."

Answered by AI

Has the Food and Drug Administration authorized Tavapadon for therapeutic use?

"The safety of Tavapadon is estimated to be a 1, as this clinical trial is in its initial phases. Thus far, the data collected has been insufficient to verify efficacy or confirm complete safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function
2022. "To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05404542.
~5 spots leftby Apr 2025
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