Tavapadon for deteriorating renal function

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Pharma, 2950 NW 83rd Street, Miami, FL
deteriorating renal function+1 More
Tavapadon - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions

  • deteriorating renal function

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for deteriorating renal function

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 Time t (AUC0-t) of Tavapadon
Maximum Observed Plasma Concentration (Cmax) of Tavapadon

Trial Safety

Safety Progress

1 of 3

Other trials for deteriorating renal function

Trial Design

2 Treatment Groups

Severe Renal Impairment
1 of 2
Normal Renal Function
1 of 2
Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Tavapadon · No Placebo Group · Phase 1

Severe Renal Impairment
Drug
Experimental Group · 1 Intervention: Tavapadon · Intervention Types: Drug
Normal Renal 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: Advanced Pharma, 2950 NW 83rd Street · Miami, FL
Photo of Miami 1Photo of Miami 2Photo of Miami 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching deteriorating renal function
0 CompletedClinical Trials

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
23 Previous Clinical Trials
4,330 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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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.