NCT06037031

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
Pfizer·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov
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 failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06037031
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.