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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-10

Study Completion Date

2025-02-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Renal Impairment Study for PF-06651600

NCT04037865

Renal Impairment

TERMINATED PHASE1

A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

NCT00596518

Renal Insufficiency, Chronic

COMPLETED PHASE1

A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With Reduced Kidney Function

NCT07315360

Renal Impairment Healthy

NOT_YET_RECRUITING PHASE1

Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function.

NCT04909853

Renal Impairment

COMPLETED PHASE1

PF-04634817 Renal Impairment Study

NCT01791855

Renal Insufficiency

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

No renal impairment

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Experimental

Cohort 2

Severe renal impairment

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Experimental

Cohort 3

Moderate renal impairment

Group Type EXPERIMENTAL

PF-07817883

Intervention Type DRUG

Experimental

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-07817883

Experimental

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes