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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
Select...
My BMI is between 16 and 32, and I weigh more than 99 lbs.
Select...
My kidney function has been stable recently.

Timeline

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for kidney failure include dialysis, kidney transplantation, and medications to manage symptoms and complications. Dialysis mechanically filters waste products and excess fluids from the blood, mimicking the natural function of healthy kidneys. Kidney transplantation involves replacing the failed kidney with a healthy donor kidney, restoring normal kidney function. Medications such as ACE inhibitors, ARBs, and diuretics help control blood pressure, reduce proteinuria, and manage fluid balance. Understanding the pharmacokinetics of drugs like PF-07923568 in patients with kidney failure is crucial because impaired kidney function can alter drug metabolism and excretion, necessitating dosage adjustments to avoid toxicity and ensure therapeutic efficacy.

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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
4,583 Previous Clinical Trials
14,635,509 Total Patients Enrolled
2 Trials studying Kidney Failure
73 Patients Enrolled for Kidney Failure
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,488 Previous Clinical Trials
11,812,460 Total Patients Enrolled
3 Trials studying Kidney Failure
194 Patients Enrolled for Kidney Failure
~3 spots leftby Aug 2024
Unbiased ResultsWe believe in providing patients with all the options.
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