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

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06037031
Collaborator
(none)
24
Enrollment
3
Arms
5.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Drug: PF-07923568
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Oct 4, 2023
Anticipated Primary Completion Date :
Mar 12, 2024
Anticipated Study Completion Date :
Mar 12, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Plasma Concentration (Cmax) [Baseline through Day 5]

    2. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [Baseline through Day 5]

    3. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [Baseline through Day 5]

    Secondary Outcome Measures

    1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [Baseline through Day 36]

    2. Number of Participants With Change From Baseline in Laboratory Tests Results [Baseline through Day 5]

    3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Baseline through Day 5]

    4. Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs) [Baseline through Day 5]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 16-32 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT06037031
    Other Study ID Numbers:
    • C5241016
    First Posted:
    Sep 14, 2023
    Last Update Posted:
    Sep 14, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Renal Insufficiency

    Study Results

    No Results Posted as of Sep 14, 2023