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PF-07923568 for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 days
Awards & highlights

Study Summary

This trial will examine how the study medicine is broken down in people with different levels of liver function loss compared to healthy people. Participants will receive a one-time dose and will stay at the clinic for 6 days for safety review. 28-35 days later, they'll have a follow up visit.

Who is the study for?
This trial is for adults over 18 with varying levels of liver function, from healthy to severe liver disease. Participants must have a BMI between 17.5 and 38 kg/m2, weigh more than 50 kg (110 lb), and be able to consent. They should not have significant medical issues based on history, exams, or tests.Check my eligibility
What is being tested?
The study is testing how PF-07923568, taken as four capsules once, is processed in people with different stages of liver health. Everyone stays at the clinic for six days post-dose for safety monitoring and lab work to track how the medicine breaks down.See study design
What are the potential side effects?
Specific side effects are not listed but participants will be closely monitored for any adverse reactions during their six-day stay at the clinic following dosing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Plasma concentrations of PF-07923568 will be listed and descriptively summarized by nominal PK sampling time and treatment.
Secondary outcome measures
Assessment of Treatment emergent adverse events
Number of participants with abnormal Vital Signs
Number of participants with abnormal electrocardiogram (ECG) readings
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Severe Hepatic Impaired SubjectsExperimental Treatment1 Intervention
One time dose of 4 capsules taken orally.
Group II: Moderate hepatic impaired subjectsExperimental Treatment1 Intervention
One time dose of 4 capsules taken orally
Group III: Mild Hepatic impaired subjectsExperimental Treatment1 Intervention
One time dose of 4 capsules taken orally.
Group IV: Healthy subjectsExperimental Treatment1 Intervention
One time dose of 4 capsules taken orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07923568
2023
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,845 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,013 Total Patients Enrolled

Media Library

PF-07923568 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05857644 — Phase 1
Liver Disease Research Study Groups: Severe Hepatic Impaired Subjects, Healthy subjects, Mild Hepatic impaired subjects, Moderate hepatic impaired subjects
Liver Disease Clinical Trial 2023: PF-07923568 Highlights & Side Effects. Trial Name: NCT05857644 — Phase 1
PF-07923568 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05857644 — Phase 1

Frequently Asked Questions

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

Does this trial embrace participants who are younger than 25 years of age?

"This medical study is open for enrolment to individuals who are aged 18 and above, up until the age of 75."

Answered by AI

Are there any attendant risks to patients participating in this Healthy subjects trial?

"A score of 1 has been assigned to the safety record of healthy individuals, as this is a Phase 1 trial and thus far only rudimentary data surrounding its efficacy and security are available."

Answered by AI

Are there any vacancies available for individuals interested in participating in this experiment?

"Yes, according to clinicaltrials.gov data, this medical trial is currently accepting patients. Initially posted on June 9th 2023 and recently updated on the 21st of the same month, 28 people need to be recruited from 3 facilities."

Answered by AI

How many individuals have been recruited into this experiment?

"Right. The information displayed on clinicaltrials.gov verifies that this trial, which was originally posted on June 9th 2023 is actively searching for participants. A total of 28 patients must be enrolled at 3 distinct medical centres."

Answered by AI

Who has the credentials to partake in this experiment?

"Those with liver disease aged between 18 and 75 are eligible for this trial. Enrolment is limited to 28 subjects in total."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.
2023. "A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05857644.
~15 spots leftby Apr 2025
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