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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Drug: PF-07923568	A single dose of PF-07923568 administered orally as 4 capsules

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-07-03
• Completion: 2024-07-03
• First posted: 2023-09-14
• Last updated: 2024-07-19

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study