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Completed

NCT Number: NCT06586216

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Renal Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

PF-07817883

Drug

Experimental

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of PF-07817883

    Time frame: Day 1 to Day 5

    Plasma PF-07817883 PK parameters

  2. Area under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)

    Time frame: Day 1 to Day 5

    Plasma PF-07817883 PK parameters

  3. Area under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

    Time frame: Day 1 to Day 5

    Plasma PF-07817883 parameters

Secondary outcomes

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

    Time frame: Screening to Day 35

    Safety Parameter

  2. Number of participants with Treatment Emergent Adverse Events

    Time frame: Day 1 to Day 35

    Safety Parameter

  3. Number of participants with Clinically Significant ECG Abnormalities

    Time frame: Day 1 to Day 5

  4. Number of participants with Clinically Significant Abnormal Vital Signs

    Time frame: Day 1 to Day 5

  5. Number of participants with Clinically Significant abnormal laboratory values.

    Time frame: Baseline to Day 5

  6. Number of participants with Serious Adverse Events

    Time frame: Screening to Day 35

    Safety parameters

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Feb 19, 2025

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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