A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function - Trial NCT06037031

Name: Clinical Trial NCT06037031
Creator: Pfizer
Keywords: Renal Impairment, Drug: PF-07923568, Phase 1, drug, clinical trial, United States of America

Access comprehensive clinical trial information for NCT06037031 through Pure Global AI's free database. This Phase 1 trial is sponsored by Pfizer and is currently Recruiting. The study focuses on Renal Impairment. Target enrollment is 24 participants.

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NCT06037031

Phase 1

Recruiting

drug

Trial Details

ClinicalTrials.gov • NCT06037031

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

A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, SINGLE-DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07923568 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION

Study Focus

Disease/Condition

Renal Impairment

Drug/Device/Intervention

Drug: PF-07923568

Study Type

Interventional

Intervention Type

drug

Sponsor & Location

Primary Sponsor

Pfizer

Location

Orlando,Tampa,Saint Paul,San Antonio,San Antonio, United States of America

Timeline & Enrollment

Phase

Phase 1

Start Date

Oct 30, 2023

End Date

Aug 01, 2024

Enrollment

24 participants

Primary Outcome

Maximum Observed Plasma Concentration (Cmax),Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf),Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Summary

The purpose of this study is to understand how the loss of kidney function affects study medicine (PF-07923568) in the body. People with some level of loss of kidney function may process PF-07923568 differently from healthy people. PF-07923568 is developed as a possible treatment for respiratory syncytial virus (RSV) infection. RSV is a common virus that affects the lungs and usually causes mild, cold-like symptoms. RSV can cause severe lung infections in infants, elderly, and adults with other serious medical conditions.  This study is seeking participants who:  - Have less than 25% difference in kidney function between 2 screening visits.  - Meet the eGFR criteria for being assigned to groups. eGFR tells how well the kidney is filtering.  - Are not on hemodialysis. Hemodialysis is a type of treatment that helps the body remove extra fluid and waste products from the blood when the kidneys are not able to.  Participants will take the study medicine as capsules by mouth once at the study clinic. The participants will stay at the study clinic for about 5 days. During that time, the study team will monitor the participants. The study team will take some blood samples to test the level of PF-07923568. This will help us understand if some level of loss of kidney function will have an effect on the study medicine PF-07923568.

ICD-10 Classifications

Renal failure

Disorders resulting from impaired renal tubular function

Disorder resulting from impaired renal tubular function, unspecified

Other disorders resulting from impaired renal tubular function

Acute renal failure

Data Source

Registry

ClinicalTrials.gov

Trial ID

NCT06037031

Type

Non-Device Trial