A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.

Last updated: February 18, 2025
Sponsor: Pfizer
Overall Status: Completed

Phase

1

Condition

Renal Failure

Kidney Failure (Pediatric)

Covid-19

Treatment

PF-07817883

Clinical Study ID

NCT06586216
C5091015
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the study is to learn about:

  • how PF-07817883 is processed in the body of adult participants.

  • the safety of PF-07817883.

These participants will have different levels of kidney function loss:

  • moderate

  • severe

  • none or healthy Participants with moderate, severe or no loss of kidney function may be taken into one of 3 groups.

This study is seeking for participants who:

  • are male or female of 18 to 90 years of age.

  • have different levels of damage to kidney function or for one of the groups, no damage

  • are willing to follow the requirements of the study including stay at clinic for 5 nights and 6 days.

About, 8 participants may be selected in groups 2 and 3. In group 1, around 8 to 12 participants may be selected. If participants agree to take part in the study, it may take up to 4 weeks to complete all the tests to confirm if they are fit to be in the study. If they seem to be fit for the study, participants will be admitted to a clinic research unit (CRU) at least 8 hours before dosing.

On Day 1, participants will receive a single amount of study medicine (Day 1). A series of blood samples will be collected before and after giving medicines. Participants will be discharged from the CRU on Day 5. A follow-up phone call (or CRU visit, if needed), will occur 28-35 days after taking the medicine. The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants aged 18 (or the minimum age of consent in accordancewith local regulations) to 90 years of age at screening.

  • BMI of ≥16 kg/m2 and a total body weight >45 kg (99 lbs).

  • Stable renal function, defined as the eGFR values obtained at the two screeningvisits should not be more than 25% different.

Exclusion

Exclusion Criteria:

  • Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV
  1. infection at the time of screening or Day -1.

  • History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitisC; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg),hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception,a positive hepatitis B surface antibody (HBsAb) test due to hepatitis B vaccinationis allowed.

  • Renal transplant recipients.

  • Any condition possibly affecting drug absorption

Study Design

Total Participants: 16
Treatment Group(s): 1
Primary Treatment: PF-07817883
Phase: 1
Study Start date:
September 10, 2024
Estimated Completion Date:
February 13, 2025

Connect with a study center

  • Clinical Pharmacology of Miami

    Miami, Florida 33014
    United States

    Site Not Available

  • Genesis Clinical Research, LLC

    Tampa, Florida 33603
    United States

    Site Not Available

  • Prism Research LLC dba Nucleus Network

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

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