← Back to Search

Other

PF-07817883 for Liver Disease

Phase 1

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 35

Awards & highlights

Study Summary

This trial aims to learn about the safety of a medicine, and how it's processed in the body of adults with different degrees of liver damage. Participants must meet criteria and may spend up to 10 weeks in the study.

Who is the study for?

Adults aged 18-75 with varying degrees of liver function damage, or no damage at all, are eligible for this study. They must have a BMI between 17.5 to 38 kg/m2 and be able to stay in the clinic for nearly a week. Those with severe health issues like uncontrolled hypertension, recent transplants, or conditions affecting drug absorption cannot participate.Check my eligibility

What is being tested?

The trial is testing PF-07817883's safety and how it's processed by adults with different levels of liver function loss. Participants will receive one dose of the medication and undergo blood tests before and after dosing during their clinic stay.See study design

What are the potential side effects?

Since this is a study to learn about the safety profile of PF-07817883, potential side effects are not explicitly listed but may include typical drug-related reactions such as nausea, headaches, allergic reactions or other unforeseen effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 35

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 35

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 35 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Maximum Observed Plasma Concentration (Cmax) of PF-07817883

Secondary outcome measures

Number of Participants with Clinically Significant Abnormal Laboratory Values

Number of Participants with Clinically Significant Abnormal Vital Signs

Number of Participants with Clinically Significant ECG Abnormalities

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment1 Intervention

Severe hepatic impairment

Group II: Cohort 3Experimental Treatment1 Intervention

Moderate hepatic impairment

Group III: Cohort 2Experimental Treatment1 Intervention

Mild hepatic impairment

Group IV: Cohort 1Experimental Treatment1 Intervention

No hepatic impairment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF-07817883

2022

Completed Phase 2

~350

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,942 Total Patients Enrolled

67 Trials studying COVID-19

1,437,143 Patients Enrolled for COVID-19

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,160 Total Patients Enrolled

49 Trials studying COVID-19

1,425,920 Patients Enrolled for COVID-19

Media Library

PF-07817883 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05884554 — Phase 1

COVID-19 Research Study Groups: Cohort 1, Cohort 4, Cohort 2, Cohort 3

COVID-19 Clinical Trial 2023: PF-07817883 Highlights & Side Effects. Trial Name: NCT05884554 — Phase 1

PF-07817883 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05884554 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to enroll individuals over the age of 20 in this research endeavor?

"The upper and lower age limits for this trial are 75 years old and 18 years old respectively."

Answered by AI

Who is eligible to join this clinical investigation?

"Applicants need to have contracted sars-cov-2 and be between 18 and 75 years old in order to meet the eligibility criteria of this clinical trial. Approximately 40 individuals can participate."

Answered by AI

Has Cohort 4 been given the green light by regulatory authorities?

"There is limited clinical evidence to support the safety of Cohort 4, so it was assigned a score of 1."

Answered by AI

What is the current enrolment size of this experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, enrollment for this medical trial is ongoing since it was initially posted on June 15th 2023 and subsequently revised on June 26th 2023. 40 patients need to be recruited from 3 different locations."

Answered by AI

What aims is this clinical trial hoping to achieve?

"According to the study sponsor, Pfizer, Area Under the Plasma Concentration-time Profile from Time Zero to the Time of Last Quantifiable Concentration (AUClast) will be assessed across Day 1 - 6. Additionally, secondary objectives are Treatment Emergent Adverse Events as Safety Parameters, Clinically Significant ECG Abnormalities such as QTcF and Heart Rate readings alongside Blood Hematology and Chemistry along with Urinalysis results."

Answered by AI

Is this research program currently accepting participants?

"Yes, according to clinicaltrials.gov this trial is currently seeking participants. On June 15th 2023, the study was first posted and has been amended as recently as 26th of the same month. Forty individuals are sought from 3 separate sites for this research project."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.

2023. "A Study to Learn About How Loss of Liver Function Affects the Blood Levels of the Study Medicine Called PF-07817883.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05884554.

All > Covid 19