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

NCT06037031 | Completed Phase 1 FDA Drug

• 1 other identifier: C5241016
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (3)

Cohort 1: Severe Renal Impairment

EXPERIMENTAL

Participants with severe renal impairment will receive a single oral dose of PF-07923568

Drug: Drug: PF-07923568

Cohort 2: Normal Renal Function

EXPERIMENTAL

Participants with normal renal function will receive a single oral dose of PF-07923568

Drug: Drug: PF-07923568

Cohort 3 (Optional): Moderate Renal Impairment

EXPERIMENTAL

Participants with moderate renal impairment will receive a single oral dose of PF-07923568

Drug: Drug: PF-07923568

Interventions

Drug: PF-07923568 DRUG

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

Also known as: Sisunatovir

Cohort 1: Severe Renal Impairment; Cohort 2: Normal Renal Function; Cohort 3 (Optional): Moderate Renal Impairment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable renal function defined as ≤25% difference between 2 measurements of absolute estimated glomerular filtration rate (eGFR) during screening.
• Meet the eGFR criteria for cohort placement during the screening period.
• Body mass index (BMI) of 16-40 kg/m2; and a total body weight \>45 kg (99 lb.).
• 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.

You may not qualify if:

• Participants with acute renal disease.
• Participants who are clinically nephrotic.
• Participants requiring hemodialysis.
• Renal allograft recipients.
• Participants who have previously received a kidney, liver, or heart transplant.
• Urinary incontinence without catheterization.
• 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).
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
• Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (6)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

Location

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78212, United States

Location

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, 78229, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency

Interventions

sisunatovir

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 14, 2023
• Study Start: October 30, 2023
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)