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Bocidelpar (ASP0367): Severe Renal Impairment for Kidney Failure

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

Study Summary

This trial is to study how a new potential treatment called ASP0367 works in people with different levels of kidney function. Participants will stay in a research unit for 6 days and 5 nights, during which they will take the medication once and have various tests and checkups. There will be one follow-up visit 9-11 days after their last stay.

Eligible Conditions
  • Kidney Failure
  • 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetics (PK) of Bocidelpar (ASP0367) in Plasma: Area Under The Concentration-time Curve From The Time of Dosing to The Last Measurable Concentration (AUClast)
Pharmacokinetics (PK) of Bocidelpar (ASP0367) in Plasma: Area Under The Concentration-time Curve From Time of Dosing Extrapolated to Time Infinity (AUCinf)
Pharmacokinetics (PK) of Bocidelpar (ASP0367) in Plasma: apparent clearance (CL/F)
+1 more
Secondary outcome measures
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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Bocidelpar (ASP0367): Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants with severe renal impairment will receive a single dose of Bocidelpar (ASP0367) under fasting conditions on day 1.
Group II: Bocidelpar (ASP0367): Normal Renal FunctionExperimental Treatment1 Intervention
Participants with normal renal function will receive a single dose of Bocidelpar (ASP0367) under fasting conditions on day 1.
Group III: Bocidelpar (ASP0367): Moderate Renal ImpairmentExperimental Treatment1 Intervention
Participants with moderate renal impairment will receive a single dose of Bocidelpar (ASP0367) under fasting conditions on day 1.
Group IV: Bocidelpar (ASP0367): Mild Renal ImpairmentExperimental Treatment1 Intervention
Participants with mild renal impairment will receive a single dose of Bocidelpar (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
192 Previous Clinical Trials
121,049 Total Patients Enrolled
Executive Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
25 Previous Clinical Trials
8,239 Total Patients Enrolled

Frequently Asked Questions

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

Am I eligible to partake in the current clinical trial?

"Eligibility criteria for this trial demands that participants must have renal insufficiency and be between 18-75 years of age. Approximately 36 patients are needed to partake in the study."

Answered by AI

Are there any hazardous effects associated with ASP0367 usage?

"As this is a Phase 1 experiment, the safety profile of ASP0367 has been rated at 1 due to the scarcity of evidence surrounding its efficacy and potential side effects."

Answered by AI

Are there any remaining slots available in this clinical investigation?

"Affirmative. According to the data on clinicaltrials.gov, this trial which was initially posted on December 16th 2021 is currently looking for participants. The study requires 36 individuals from 4 different medical sites."

Answered by AI

What is the principal aim of this trial?

"The primary goal of this investigation, which is to be conducted over a period not exceeding 5 days, is to assess the Pharmacokinetic (PK) parameters of ASP0367 in plasma by determining its Area Under The Concentration-Time Curve from Time Of Dosing To Last Measurable Concentration (AUClast). Secondary objectives involve recording the Number Of Participants With Adverse Events (AEs), Vital Sign Abnormalities &/or AEs, and Laboratory Value Abnormalities &/or AEs. All adverse events will be coded using MedDRA; an AE encompasses any unfavorable and unintended sign or symptom triggered by study"

Answered by AI

Is there a wide geographic distribution of research sites conducting the trial in the U.S.?

"This clinical trial is run by Pinnacle Research Group in Anniston, Alabama, Advanced Pharma CR LLC. located in Miami, Florida and Inland Empire based in Rialto, California as well as four other sites."

Answered by AI

What is the current participant cap for this research project?

"According to the study's parameters, 36 qualifying patients must be recruited before it can commence. Astellas Pharma Global Development, Inc., will oversee this project from multiple sites such as Pinnacle Research Group in Anniston and Advanced Pharma CR, LLC located in Miami."

Answered by AI

Does this research protocol include adults aged 25 or above?

"This clinical trial necessitates that participants are aged above 18 and below 75."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Alabama
How old are they?
18 - 65
What site did they apply to?
Pinnacle Research Group
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People
2021. "A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05117294.
~4 spots leftby Apr 2025
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