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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06037031
• Other study ID #: C5241016
• Status: Recruiting
• Phase: Phase 1
• Start date: October 30, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Prism Research LLC dba Nucleus Network	Saint Paul	Minnesota
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	Genesis Clinical Research, LLC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		Baseline through Day 5
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)		Baseline through Day 5
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)		Baseline through Day 5
Secondary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		Baseline through Day 36
Secondary	Number of Participants With Change From Baseline in Laboratory Tests Results		Baseline through Day 5
Secondary	Number of Participants With Clinically Significant Change From Baseline in Vital Signs		Baseline through Day 5
Secondary	Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)		Baseline through Day 5

External Links

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