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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

Study 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%
Headache
25%
Hypoglycaemia
25%
Abdominal pain
25%
Nausea
14%
Lacrimation increased
13%
Dizziness
13%
Transaminases increased
13%
Metabolic acidosis
13%
Dyspnoea
13%
Constipation
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
4,567 Previous Clinical Trials
10,911,849 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,017 Total Patients Enrolled

Frequently Asked Questions

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

Could you provide an update on the current enrollment status of this research endeavor?

"As demonstrated by clinicaltrials.gov, this research trial is actively seeking volunteers. The study's initial posting was on August 1st 2022 and the most recent update happened October 10th of that same year."

Answered by AI

How many volunteers are taking part in the clinical experiment?

"Affirmative. The information provided on clinicaltrials.gov attests that this medical study is currently recruiting patients, which was initially posted on August 1st 2022 and recently updated October 10th 2022. 24 participants are required from three particular sites for enrolment in the trial."

Answered by AI

Is eligibility for the trial limited to people aged 20 and under?

"This particular clinical trial has set the upper age limit to 70 and a lower limit of 18. Additionally, there are 77 studies available for minors while 589 are accessible to those over 65 years old."

Answered by AI

Could I enroll in this medical research project?

"This medical trial is recruiting 24 patients that have hepatic impairment and reside between the ages of 18 to 70. Those interested must fulfill these criteria in order to be considered for participation."

Answered by AI

Could you elucidate the risks associated with PF-07081532 administration?

"Based on the limited data available for PF-07081532, Power has established a safety rating of 1. This is because this product is currently at Phase 1 and does not have substantial evidence supporting its efficacy or lack thereof."

Answered by AI
~9 spots leftby Apr 2025