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

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL STUDY TO ASSESS THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH RENAL IMPAIRMENT AND HEALTHY ADULT PARTICIPANTS WITH NORMAL RENAL FUNCTION

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: PF-07817883

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Tampa, Florida, United States, 33603
      • Genesis Clinical Research, LLC
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Prism Research LLC dba Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female participants aged 18 (or the minimum age of consent in accordance with 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 screening visits should not be more than 25% different.

Exclusion Criteria:

• Positive test result for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) infection at the time of screening or Day -1.
• History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; 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 vaccination is allowed.
• Renal transplant recipients.
• Any condition possibly affecting drug absorption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; No renal impairment	Drug: PF-07817883; Experimental
Experimental: Cohort 2; Severe renal impairment	Drug: PF-07817883; Experimental
Experimental: Cohort 3; Moderate renal impairment	Drug: PF-07817883; Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of PF-07817883	Plasma PF-07817883 PK parameters	Day 1 to Day 5
Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)	Plasma PF-07817883 PK parameters	Day 1 to Day 5
Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)	Plasma PF-07817883 parameters	Day 1 to Day 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Non-Serious Adverse Events (NSAE)	Safety Parameter	Screening to Day 35
Number of participants with Treatment Emergent Adverse Events	Safety Parameter	Day 1 to Day 35
Number of participants with Clinically Significant ECG Abnormalities		Day 1 to Day 5
Number of participants with Clinically Significant Abnormal Vital Signs		Day 1 to Day 5
Number of participants with Clinically Significant abnormal laboratory values.		Baseline to Day 5
Number of participants with Serious Adverse Events	Safety parameters	Screening to Day 35

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Actual): February 13, 2025
• Study Completion (Actual): February 13, 2025

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19; Renal Impairment
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Renal Insufficiency
• Other Study ID Numbers: C5091015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No