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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: Drug: PF-07923568

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32809
      • Recruiting
      • Orlando Clinical Research Center
    • Tampa, Florida, United States, 33603
      • Recruiting
      • Genesis Clinical Research, LLC
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Recruiting
      • Prism Research LLC dba Nucleus Network
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Clinical Trials of Texas, LLC
    • San Antonio, Texas, United States, 78212
      • Recruiting
      • Clinical Trials of Texas, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening.
2. Meet the eGFR criteria for cohort placement during the screening period.
3. Body mass index (BMI) of 16-40 kg/m2; and a total body weight >45 kg (99 lb.).
4. For Cohort 2 Normal Renal Function Group Only: At screening, meet the demographic-matching criteria, including body weight within ±15 kg and age within ±10 years, of the average of the pooled renal impairment cohort.

Exclusion Criteria:

1. Participants with acute renal disease.
2. Participants who are clinically nephrotic.
3. Participants requiring hemodialysis.
4. Renal allograft recipients.
5. Participants who have previously received a kidney, liver, or heart transplant.
6. Urinary incontinence without catheterization.
7. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
8. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
9. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Severe Renal Impairment; Participants with severe renal impairment will receive a single oral dose of PF-07923568	Drug: Drug: PF-07923568; A single dose of PF-07923568 administered orally as 4 capsules; Other Names: Sisunatovir
Experimental: Cohort 2: Normal Renal Function; Participants with normal renal function will receive a single oral dose of PF-07923568	Drug: Drug: PF-07923568; A single dose of PF-07923568 administered orally as 4 capsules; Other Names: Sisunatovir
Experimental: Cohort 3 (Optional): Moderate Renal Impairment; Participants with moderate renal impairment will receive a single oral dose of PF-07923568	Drug: Drug: PF-07923568; A single dose of PF-07923568 administered orally as 4 capsules; Other Names: Sisunatovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Baseline through Day 5
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	Baseline through Day 5
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Baseline through Day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Baseline through Day 36
Number of Participants With Change From Baseline in Laboratory Tests Results	Baseline through Day 5
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Baseline through Day 5
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)	Baseline through Day 5

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency
• Other Study ID Numbers: C5241016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No