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Completed

NCT Number: NCT06037031

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Drug: PF-07923568

Drug

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

Other names: Sisunatovir

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Baseline through Day 5

  2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

    Time frame: Baseline through Day 5

  3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Baseline through Day 5

Secondary outcomes

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Time frame: Baseline through Day 36

  2. Number of Participants With Change From Baseline in Laboratory Tests Results

    Time frame: Baseline through Day 5

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Time frame: Baseline through Day 5

  4. Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)

    Time frame: Baseline through Day 5

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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