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

NCT06586216 | Completed Phase 1 FDA Drug

• 1 other identifier: C5091015
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

COVID-19

Keywords

Renal Impairment; COVID-19

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Number of participants with Non-Serious Adverse Events (NSAE)

  Screening to Day 35

• Number of participants with Treatment Emergent Adverse Events

  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

Study Arms (3)

Cohort 1

EXPERIMENTAL

No renal impairment

Drug: PF-07817883

Cohort 2

EXPERIMENTAL

Severe renal impairment

Drug: PF-07817883

Cohort 3

EXPERIMENTAL

Moderate renal impairment

Drug: PF-07817883

Interventions

PF-07817883 DRUG

Experimental

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (3)

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Genesis Clinical Research, LLC

Tampa, Florida, 33603, United States

Location

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Related Links

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

MeSH Terms

Conditions

COVID-19; Renal Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)