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PF-07081532 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 29
Awards & highlights

Summary

This trial will study how different degrees of liver damage affect the way a person's body processes a drug called PF-07081532.

Eligible Conditions
  • Liver Disease
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 29 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 extrapolated to infinite time (AUCinf)
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)
Fraction of unbound drug in plasma (fu)
+4 more
Secondary outcome measures
Number of participants with treatment emergent adverse events (AEs)
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
+1 more

Side effects data

From 2021 Phase 1 trial • 66 Patients • NCT04305587
50%
Early satiety
50%
Diarrhoea
25%
Abdominal pain
25%
Headache
25%
Hypoglycaemia
25%
Nausea
14%
Lacrimation increased
13%
Metabolic acidosis
13%
Dizziness
13%
Dyspnoea
13%
Constipation
13%
Transaminases increased
13%
Thrombocytopenia
13%
Hypokalaemia
13%
Leukocytosis
13%
Ocular hyperaemia
13%
Sepsis
13%
Vomiting
13%
Ovarian cyst
13%
Bandaemia
13%
Obstructive pancreatitis
13%
Cholelithiasis
13%
Acute kidney injury
13%
Hypotension
13%
Arteriosclerosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Part A
PF-07081532 30 mg Part A
PF-07081532 10 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

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
4,595 Previous Clinical Trials
12,868,746 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,045,355 Total Patients Enrolled
~8 spots leftby Jul 2025
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