STUDY OF PF-06882961 IN PARTICIPANTS WITH AND WITHOUT VAR... | NCT04604496

NCT04604496

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PF-06882961 participants without Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1	Drug: PF-06882961 20MG
PF-06882961 participants with mild Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1	Drug: PF-06882961 20MG
PF-06882961 participants with moderate Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1	Drug: PF-06882961 20MG
PF-06882961 participants with severe Hepatic Impairment	Experimental	This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1	Drug: PF-06882961 20MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PF-06882961 20MG	Drug	PF-06882961 in 20 mg oral tablet will be administered on Day 1	PF-06882961 participants with mild Hepatic Impairment PF-06882961 participants with moderate Hepatic Impairment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Plasma Concentration (Cmax)	Maximum observed plasma PF-06882961 concentration.	Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)	Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.	Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 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)	Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.	Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.
Fraction of Unbound Drug in Plasma (fu)	fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).	Predose (0 hours), and 4 hours post dose on Day 1.

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Treatment-emergent Adverse Events (AEs)	Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. AEs included SAEs and non-serious AEs. Serious AEs (SAEs) were any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). Treatment-related TEAEs were any untoward medical occurrence attributed to study treatment. Relatedness to study treatment was determined by the investigator.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female participants between the ages of 18 (or the minimum country-specific age of consent if >18) and 70 years, inclusive, at the screening visit:
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body mass index (BMI) of 17.5 to 38.0 kg/m2, inclusive; and a total body weight >50 kg (110 lb), at the screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed.

Exclusion Criteria:

Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection); NOTE: Participants who have undergone cholecystectomy and/or appendectomy are eligible for this study as long as the surgery occurred more than 6 months prior to Screening;
At screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed;
A positive COVID-19 test at screening;
A diagnosis of type 2 diabetes mellitus (T2DM) that is documented by medical history;
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or participants with suspected MTC per the investigator's judgement;
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study;
Use of prior/concomitant therapies
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer);
Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06882961;
Participants with ANY of the following abnormalities in clinical laboratory tests at Visit 1, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

HbA1c ≥6.5%; FPG ≥126 mg/Dl; eGFR<60 mL/min/1.73m2;

A positive urine drug test, for illicit drugs at screening, as assessed by sponsor-identified central laboratory. However, participants in Cohorts 2-4, only, who have been medically prescribed opiates/opioids or benzodiazepines and report the use of these drugs to the investigator at the Screening visit will be allowed to participate; NOTE: repeat urine drug testing is not permitted in this study;
At screening or Day -1, a positive breath alcohol test, as assessed using kits provided by sponsor-identified central laboratory, with a single repeat on a separate day permitted to assess eligibility, if needed;
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact; 13. History of sensitivity to heparin or heparin-induced thrombocytopenia, only if heparin is used to flush intravenous catheters used during serial blood collections;
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

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

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami Division of Clinical Pharmacology		Miami	Florida	33136	United States
Orlando Clinical Research Center

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

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Without Hepatic Impairment	Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1.
FG001	Mild Hepatic Impairment	Participants with mild hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1.
FG002	Moderate Hepatic Impairment	Participants with moderate hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1.
FG003	Severe Hepatic Impairment	Participants with severe hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1.

ID	Title	Description
BG000	Without Hepatic Impairment	Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1.
BG001	Mild Hepatic Impairment

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

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)

Maximum observed plasma PF-06882961 concentration.

The analysis population refers to all participants who received at least 1 dose of PF-06882961 and had at least 1 of the pharmacokinetic (PK) parameters of interest calculated.

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36 and 48 hours post dose on Day 1.

ID	Title	Description
OG000	Without Hepatic Impairment	Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state on Day 1.
OG001	Mild Hepatic Impairment

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	Participants without hepatic impairment received a single, oral dose of PF-06882961 20 mg in the fed state 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	Oct 5, 2020	Oct 24, 2022	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Dec 10, 2020	Oct 24, 2022	SAP_001.pdf