PF-07081532 for Hepatic Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Genesis Clinical Research, Tampa, FL
Hepatic Impairment+2 More
PF-07081532 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The primary purpose of this study is to characterize the effect of varying degrees of hepatic impairment on the plasma pharmacokinetics (PK) of PF-07081532 following administration of a single oral dose of PF-07081532.

Eligible Conditions

  • Hepatic Impairment
  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 4 Secondary · Reporting Duration: Baseline to Day 29

Baseline to Day 29
Number of participants with treatment emergent adverse events (AEs)
Baseline to Day 7
Number of participants with treatment emergent clinically significant abnormal electrocardiograms (ECG)
Number of participants with treatment emergent clinically significant change from baseline in vital signs
Number of participants with treatment emergent clinically significant clinical laboratory abnormalities
Day 1
Fraction of unbound drug in plasma (fu)
up to day 7
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Maximum plasma concentration (Cmax)
Unbound area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf,u)
Unbound area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast,u)
Unbound maximum plasma concentration (Cmax, u)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Group 2: PF-07081532 Participants with mild hepatic impairment
1 of 4
Group 1: PF-07081532 Participants without hepatic impairment
1 of 4
Group 3: PF-07081532 Participants with moderate hepatic impairment
1 of 4
Group 4: PF-07081532 Participants with severe hepatic impairment
1 of 4
Experimental Treatment

24 Total Participants · 4 Treatment Groups

Primary Treatment: PF-07081532 · No Placebo Group · Phase 1

Group 2: PF-07081532 Participants with mild hepatic impairment
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
Group 1: PF-07081532 Participants without hepatic impairment
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
Group 3: PF-07081532 Participants with moderate hepatic impairment
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
Group 4: PF-07081532 Participants with severe hepatic impairment
Drug
Experimental Group · 1 Intervention: PF-07081532 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07081532
2020
Completed Phase 1
~130

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to day 29
Closest Location: Genesis Clinical Research · Tampa, FL
Photo of Tampa 1Photo of Tampa 2Photo of Tampa 3
2016First Recorded Clinical Trial
1 TrialsResearching Hepatic Impairment
12 CompletedClinical Trials

Who is running the clinical trial?

PfizerLead Sponsor
4,229 Previous Clinical Trials
6,666,557 Total Patients Enrolled
9 Trials studying Hepatic Impairment
193 Patients Enrolled for Hepatic Impairment
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,226 Previous Clinical Trials
4,383,406 Total Patients Enrolled
9 Trials studying Hepatic Impairment
204 Patients Enrolled for Hepatic Impairment

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Group 1: No clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
You have no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.
You are between the ages of 18 and 70 years, inclusive at the screening visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.