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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

NCT06037031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-07-19

No results posted yet for this study

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.

Conditions

  • Renal Impairment

Interventions

DRUG

Drug: PF-07923568

A single dose of PF-07923568 administered orally as 4 capsules

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-07-03
Completion
2024-07-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06037031 on ClinicalTrials.gov