A Study to Understand How the Study Medicine (PF-07081532... | NCT05478603

NCT05478603

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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	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.	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.	Drug: PF-07081532

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-07081532	Drug	PF-07081532 20 milligrams (mg), 1 tablet orally, once on Day 1	Group 1: PF-07081532 Participants without hepatic impairment Group 2: PF-07081532 Participants with mild hepatic impairment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax) of PF-07081532	Cmax is the maximum plasma concentration.	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.	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.	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).	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.	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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Orlando Clinical Research Center		Orlando	Florida	32809	United States
Genesis Clinical Research, LLC

Label	URL
To obtain contact information for a study center near you, click here.	View source

ID	Title	Description
FG000	Without Hepatic Impairment	This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1.
FG001	Mild Hepatic Impairment	This arm included participants with mild hepatic impairment who received PF-07081532 20mg on Day 1.
FG002	Moderate Hepatic Impairment	This arm included participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1.
FG003	Severe Hepatic Impairment	This arm included participants with severe hepatic impairment who received PF-07081532 20mg on Day 1.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Without Hepatic Impairment	This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1.
BG001	Mild Hepatic Impairment	This arm included participants with mild hepatic impairment who received PF-07081532 20mg on Day 1.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Plasma Concentration (Cmax) of PF-07081532

Cmax is the maximum plasma concentration.

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.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

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

ID	Title	Description
OG000	Without Hepatic Impairment	Participants without hepatic impairment who received PF-07081532 20mg on Day 1
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Without Hepatic Impairment	This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 18, 2022	Apr 3, 2024	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Aug 10, 2022	Apr 3, 2024	SAP_001.pdf