Clinical trial NCT06037031: A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Baseline through Day 5
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
timeFrame: Baseline through Day 5
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Baseline through Day 5
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
timeFrame: Baseline through Day 36
measure: Number of Participants With Change From Baseline in Laboratory Tests Results
timeFrame: Baseline through Day 5
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Baseline through Day 5
measure: Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)
timeFrame: Baseline through Day 5
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Saint Paul
country: United States
facility: Prism Research LLC dba Nucleus Network
state: Minnesota
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC dba Flourish Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: