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A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on day 1
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new medicine called PF-07081532 in adults aged 18-70 with specific BMI and weight criteria, focusing on those with liver problems. Participants will take the medicine as a tablet, and researchers will monitor how it is processed in their bodies through blood samples.

Eligible Conditions
  • Healthy Subjects
  • Liver disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on day 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 0 (prior to dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 15, 24, 36, 48, 72, 96, 120, and 144 hours post dose on day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532
Fraction of Unbound Drug in Plasma (Fu) of PF-07081532
+4 more
Secondary study objectives
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
+1 more

Side effects data

From 2021 Phase 1 trial • 66 Patients • NCT04305587
14%
Dyspepsia
14%
Diarrhoea
14%
Decreased appetite
14%
Vaccination complication
14%
Dermatitis contact
100%
80%
60%
40%
20%
0%
Study treatment Arm
PF-07081532 10 mg Part A
Placebo Part A
PF-07081532 30 mg Part A
PF-07081532 60 mg Part A
PF-07081532 120 mg Part A
Placebo Part B
PF-07081532 180 mg Part B
Placebo Part C
PF-07081532 180 mg Part C

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group 4: PF-07081532 Participants with severe hepatic impairmentExperimental Treatment1 Intervention
Participants with severe hepatic impairment will receive a single20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.
Group II: Group 3: PF-07081532 Participants with moderate hepatic impairmentExperimental Treatment1 Intervention
Participants with moderate hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.
Group III: Group 2: PF-07081532 Participants with mild hepatic impairmentExperimental Treatment1 Intervention
Participants with mild hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet
Group IV: Group 1: PF-07081532 Participants without hepatic impairmentExperimental Treatment1 Intervention
Participants without hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-07081532
2022
Completed Phase 1
~170

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,675 Previous Clinical Trials
28,717,157 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,556 Previous Clinical Trials
25,758,013 Total Patients Enrolled
~7 spots leftby Dec 2025
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