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PF-07923568 for Kidney Failure

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (99 lb.)

Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 36

Awards & highlights

Study Summary

This trial is studying how loss of kidney function affects how people process a medicine for respiratory syncytial virus (RSV). Participants must have some level of loss of kidney function and meet other criteria. They will take medicine at the clinic and stay for 5 days while the study team monitors them.

Who is the study for?

This trial is for adults with varying levels of kidney function loss, who haven't had a kidney transplant or don't need hemodialysis. They should have stable kidney function as shown by tests and meet specific body weight criteria. People with recent drug abuse history, certain infections like HIV or hepatitis, or those on other clinical trials can't participate.Check my eligibility

What is being tested?

The study is testing PF-07923568, a potential treatment for RSV infection in people with reduced kidney function. Participants will take the medication orally once and stay at the clinic for about 5 days while their blood is tested to see how their kidneys process the drug.See study design

What are the potential side effects?

Potential side effects are not detailed here but monitoring during the clinic stay suggests they're looking out for any adverse reactions to PF-07923568 related to its processing by impaired kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 16 and 32, and I weigh more than 99 lbs.

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My kidney function has been stable recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through day 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 36 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 Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Maximum Observed Plasma Concentration (Cmax)

Secondary outcome measures

Number of Participants With Change From Baseline in Laboratory Tests Results

Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)

Number of Participants With Clinically Significant Change From Baseline in Vital Signs

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 (Optional): Moderate Renal ImpairmentExperimental Treatment1 Intervention

Participants with moderate renal impairment will receive a single oral dose of PF-07923568

Group II: Cohort 2: Normal Renal FunctionExperimental Treatment1 Intervention

Participants with normal renal function will receive a single oral dose of PF-07923568

Group III: Cohort 1: Severe Renal ImpairmentExperimental Treatment1 Intervention

Participants with severe renal impairment will receive a single oral dose of PF-07923568

0 / 2Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,958 Total Patients Enrolled

2 Trials studying Kidney Failure

73 Patients Enrolled for Kidney Failure

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,176 Total Patients Enrolled

3 Trials studying Kidney Failure

194 Patients Enrolled for Kidney Failure

Frequently Asked Questions

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

What criteria must participants of this research meet?

"This trial is in search of 24 participants, between the ages of 18 and 90, who have suffered kidney failure. Furthermore, these patients must fulfill other parameters such as a BMI ranging from 16-32 kg/m2 and a total body weight greater than 45 kilograms (99 pounds). Additionally for Cohort 2 Normal Renal Function Group Only: At screening they must meet similar demographic characteristics to those enrolled within the renal impairment cohort which includes a bodyweight that varies by no more than 15kgs away from average and an age difference no larger than 10 years."

Answered by AI

Do individuals aged seventy and above have access to the experimental protocol?

"This research is recruiting those aged 18 and above who are no longer than 90 years old."

Answered by AI

Has the FDA sanctioned Cohort 1: Severe Renal Impairment?

"Our in-house experts assigned a score of 1 to Cohort 1: Severe Renal Impairment, as this is the initial phase for which safety and efficacy are minimally documented."

Answered by AI

Are there any available vacancies in this clinical trial?

"According to the data at clinicaltrials.gov, this experiment is not currently recruiting patients even though it was first posted on October 30th 2023 and saw its last update on October 26th 2023. Despite that, there are 165 other studies actively seeking volunteers today."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function

2023. "A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06037031.