Hepatic ImpairmentPhase 1NCT05478603

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

A Phase 1 study testing PF-07081532 in people with Hepatic Impairment and Healthy Volunteers, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to understand the effects of liver functional impairment on the study medicine (PF-07081532). People with liver functional impairment may process the study medicine differently from healthy people. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Impairment, Healthy Volunteers
What is being tested?: PF-07081532
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesUnited States
Study dates: 1 Aug 2022to 5 Apr 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female between the ages of 18 and 70 years, inclusive at the screening visit.
Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
Group 1 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.
Groups 2, 3 \& 4 only: stable hepatic impairment that meets criteria for Class A, B, or C of the Child-Pugh classification with no clinically significant change in disease status within 28 days before screening.
Groups 2, 3 \& 4 only: stable concomitant medications for the management of individual participant's medical history.

Who cannot join

Any condition possibly affecting drug absorption
At screening, a positive result for HIV antibodies.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or participants with suspected MTC per study doctor's judgement.
History of acute pancreatitis within 6 months before the screening visit or any history of chronic pancreatitis.
Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
Use of specific prohibited prior/concomitant therapies

Show all 26Show fewer

Use of an investigational product within 30 days (or local requirement) or 5 half-lives (whichever longer).
eGFR<60 mL/min/1.73m2 at screening.
A positive urine drug test at screening or admission to study clinic.
At screening or admission to study clinic, a positive breath alcohol test.
For females, pregnancy, as indicated by a positive serum pregnancy test at screening and/or positive urine pregnancy test in women capable of having children at admission to study clinic
Group 1 only: evidence of chronic liver disease including history of hepatitis, hepatitis B, or hepatitis C.
Group 1 only: history of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of screening.
Group 1 only: screening ECG demonstrating QTcF interval >450 ms or a QRS interval >120 ms.
Group 1 only: screening seated systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg
Group 1 only: use of chronic prescription medications within 7 days or 5 half-lives (whichever longer) before Day 1, or for prohibited medications, use within the required washout/restriction period.
Group 2, 3 \& 4 only: Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as <1 year in Groups 2 \& 3 and <6 months for Group 4 only).
Group 2, 3 \& 4 only: a diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical exam, liver biopsy, hepatic ultrasound, CT scan, or MRI.
Group 2, 3 \& 4 only: history of surgery that would be expected to alter absorption, distribution, metabolism, or excretion properties of PF-07081532.
Group 2, 3 \& 4 only: history of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than 4 weeks prior to screening.
Group 2, 3 \& 4 only: signs of clinically active Grade 3 or 4 hepatic encephalopathy
Groups 2, 3 \& 4 only: severe ascites and/or pleural effusion, except for those categorized in Group 4 who may be enrolled provided participant is medically stable, per the study doctor's judgment.
Groups 2, 3 \& 4 only: previously received a kidney, liver, or heart transplant.
Groups 2, 3, \& 4 only: screening ECG demonstrating a QTcF interval >470 ms or a QRS interval >120 ms.
Groups 2, 3 \& 4 only: at screening, admission to study clinic or pre-dose on Day 1, persistent severe, uncontrolled hypertension.
Groups 2, 3 \& 4 only: ALT or AST >5x upper limit of normal on clinical laboratory tests at screening.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Orlando Clinical Research Center
Orlando, Florida, 32809
Genesis Clinical Research, LLC
Tampa, Florida, 33603

Other trials in United States

About this study

Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT

We are seeking participants who:

Are between 18 and 70 years of age;
Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs.).

Participants will take the study medicine as a tablet once at the study clinic, and then will stay onsite for about 7 days. During this time, the study team will monitor their treatment experience and take some blood samples to test the level of PF-07081532. This will help us understand if certain level of liver functional impairment could affect the study medicine being processed in the body.

Conditions: Hepatic Impairment, Healthy Volunteers
Being tested: PF-07081532
Keywords: Hepatic impairment, Healthy volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-07081532Drug
PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1

Study groups in NCT05478603
Study group	Role	What they receive
Group 1: PF-07081532 Participants without hepatic impairment	Experimental	Participants without hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet. Receives: Drug: PF-07081532
Group 2: PF-07081532 Participants with mild hepatic impairment	Experimental	Participants with mild hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet Receives: Drug: PF-07081532
Group 3: PF-07081532 Participants with moderate hepatic impairment	Experimental	Participants with moderate hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet. Receives: Drug: PF-07081532
Group 4: PF-07081532 Participants with severe hepatic impairment	Experimental	Participants with severe hepatic impairment will receive a single20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet. Receives: Drug: PF-07081532

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) of PF-07081532
Cmax is the maximum plasma concentration.
Measured: 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
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time.
Measured: 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
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Measured: 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
Fraction of Unbound Drug in Plasma (Fu) of PF-07081532
Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).
Measured: 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
Unbound Cmax (Cmax,u) of PF-07081532
Cmax,u is the unbound Cmax.
Measured: 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
Unbound AUCinf (AUCinf,u) of PF-07081532
AUCinf,u is the unbound AUCinf.
Measured: 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
Unbound AUClast (AUClast,u) of PF-07081532
AUClast,u is the unbound AUClast.
Measured: 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

Secondary outcomes (4)

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were defined as events that started during the effective duration of treatment (ie, starting on or after the dose of PF-07081532 up to the final follow-up visit). AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.
Measured: Day 1 to Day 36
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Safety laboratory assessments included clinical chemistry, hematology, and urinalysis tests. Number of participants with clinical laboratory abnormalities meeting pre-specified criteria is reported.
Measured: From baseline (BL) to Day 7
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Vital signs abnormalities included: seated diastolic blood pressure (BP) increase and decrease from BL of >=20mmHg or absolute value <50mmHg; systolic BP increase and decrease from BL of >=30mmHg or absolute value <90mmHg; pulse rate <40 or >120bpm.
Measured: From BL to Day 7
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
ECG assessments included PR interval, QT interval, QTcF, and QRS complex. ECG abnormalities included PR interval BL >200msec and max ≥25% increase from BL, or BL ≤200msec and max ≥50% increase from BL, or absolute value ≥300msec; QRS interval percent change from BL ≥50% or absolute value ≥140msec; QTcF change from BL 30- ≤60msec, >60msec, or absolute value 450- ≤480msec, 480- ≤500msec, or >500msec.
Measured: From BL to Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20225 Apr 2023

First posted28 Jul 2022
Study start1 Aug 2022
Primary completion5 Apr 2023
Study completion5 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05478603
Sponsor's protocol ID: C3991009
Status last verified: Apr 2024
First submitted: 26 Jul 2022
Last updated: 22 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Hepatic Impairment
RecruitingPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Hepatic Impairment
Not yet recruitingPhase 1
Aleniglipron Hepatic Impairment Study
Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
Mild Hepatic Imparement

All Hepatic Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF PF-07081532 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
ClinicalTrials.gov ID: NCT05478603
Acronym / sponsor ID: C3991009
Conditions: Hepatic Impairment, Healthy Volunteers
Keywords: Hepatic impairment, Healthy volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Aug 2022 (actual)
Primary completion: 5 Apr 2023 (actual)
Study completion: 5 Apr 2023 (actual)
First posted: 28 Jul 2022 (actual)
Results: Posted 22 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

We are seeking participants who:

Are between 18 and 70 years of age;
Have a BMI (body mass index) of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs.).

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1: PF-07081532 Participants without hepatic impairment	Experimental	Drug: PF-07081532Participants without hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.
Group 2: PF-07081532 Participants with mild hepatic impairment	Experimental	Drug: PF-07081532Participants with mild hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet
Group 3: PF-07081532 Participants with moderate hepatic impairment	Experimental	Drug: PF-07081532Participants with moderate hepatic impairment will receive a single 20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.
Group 4: PF-07081532 Participants with severe hepatic impairment	Experimental	Drug: PF-07081532Participants with severe hepatic impairment will receive a single20 mg dose of PF-07081532, administered orally as 1 PF-07081532 20 mg tablet.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female between the ages of 18 and 70 years, inclusive at the screening visit.
Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
BMI of 17.5 to 38.0 kg/m2, inclusive, and a total body weight >50 kg (110 lb).
Group 1 only: at screening, no clinically relevant abnormalities identified by a detailed medical history, physical exam, including blood pressure and pulse rate measurement, ECG and clinical laboratory tests.
Group 1 only: no known or suspected hepatic impairment and meet the criteria based on screening laboratory liver function tests.

Key exclusion criteria (26 listed)

Any condition possibly affecting drug absorption
At screening, a positive result for HIV antibodies.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2), or participants with suspected MTC per study doctor's judgement.
History of acute pancreatitis within 6 months before the screening visit or any history of chronic pancreatitis.
Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-07081532PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1	Drug	Group 1: PF-07081532 Participants without hepatic impairment, Group 2: PF-07081532 Participants with mild hepatic impairment, Group 3: PF-07081532 Participants with moderate hepatic impairment, Group 4: PF-07081532 Participants with severe hepatic impairment

Primary outcome

Maximum Plasma Concentration (Cmax) of PF-07081532
Time frame: 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
Cmax is the maximum plasma concentration.
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532
Time frame: 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
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time.
Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532
Time frame: 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
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Fraction of Unbound Drug in Plasma (Fu) of PF-07081532
Time frame: 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
Fu is the fraction of unbound drug in plasma, which is calculated by Cu/C (where Cu represents unbound concentration and C represents total concentration).
Unbound Cmax (Cmax,u) of PF-07081532
Time frame: 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
Cmax,u is the unbound Cmax.
Unbound AUCinf (AUCinf,u) of PF-07081532
Time frame: 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
AUCinf,u is the unbound AUCinf.
Unbound AUClast (AUClast,u) of PF-07081532
Time frame: 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
AUClast,u is the unbound AUClast.

4 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 to Day 36
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Time frame: From baseline (BL) to Day 7
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame: From BL to Day 7
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
Time frame: From BL to Day 7

Results and safety

Results posted to the registry on 22 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Without Hepatic Impairment	6	6
Mild Hepatic Impairment	6	5
Moderate Hepatic Impairment	6	6
Severe Hepatic Impairment	6	6

Primary outcome: Maximum Plasma Concentration (Cmax) of PF-07081532

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: nanogram per milliliter (ng/mL)

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	2236 (10)	2121 (18)	2230 (30)	1536 (49)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 94.88 (90% CI 70.86 to 127.04), ANOVA
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 99.75 (90% CI 74.50 to 133.56), ANOVA
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 68.70 (90% CI 51.31 to 91.98), ANOVA

Population analysed: The PK concentration population included all participants who each received 1 dose of PF-07081532 and in whom at least 1 plasma concentration value was reported. The PK parameter analysis population included all participants who each received 1 dose of PF-07081532 and had at least 1 of the PK parameters of interest calculated.

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	43200 (40)	44010 (61)	67430 (66)	41680 (62)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 101.87 (90% CI 59.74 to 173.71), ANOVA
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 156.07 (90% CI 91.53 to 266.14), ANOVA
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 96.48 (90% CI 56.58 to 164.51), ANOVA

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of PF-07081532

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	40990 (39)	41900 (63)	62680 (64)	39800 (63)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 102.21 (90% CI 59.91 to 174.39), ANOVA
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 152.91 (90% CI 89.62 to 260.90), ANOVA
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 97.08 (90% CI 56.90 to 165.65), ANOVA

Primary outcome: Fraction of Unbound Drug in Plasma (Fu) of PF-07081532

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: Ratio

Measure	Without Hepatic Impairment n = 6	Mild Hepatic Impairment n = 6	Moderate Hepatic Impairment n = 6	Severe Hepatic Impairment n = 6
Value	0.0002753 (12)	0.0002568 (38)	0.0002937 (19)	0.0006780 (66)

Without Hepatic Impairment vs Mild Hepatic Impairment: Ratio of adjusted geometric means: 93.29 (90% CI 64.61 to 134.69), ANOVA
Without Hepatic Impairment vs Moderate Hepatic Impairment: Ratio of adjusted geometric means: 106.68 (90% CI 73.89 to 154.03), ANOVA
Without Hepatic Impairment vs Severe Hepatic Impairment: Ratio of adjusted geometric means: 246.28 (90% CI 170.57 to 355.58), ANOVA

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 to Day 36. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Without Hepatic Impairment	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Mild Hepatic Impairment	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Moderate Hepatic Impairment	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Severe Hepatic Impairment	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Related trials for Hepatic Impairment

RecruitingPhase 1
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Hepatic Impairment
RecruitingPhase 1
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
Hepatic Impairment
Not yet recruitingPhase 1
Aleniglipron Hepatic Impairment Study
Hepatic Impairment
Not yet recruitingPhase 1
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
Not yet recruitingPhase 1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Participants With Mild Hepatic Impairment Compared With Participants With Normal Hepatic Function
Mild Hepatic Imparement

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07081532 in people with Hepatic Impairment and Healthy Volunteers, run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of PF-07081532 (time frame: 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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05478603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.