Trial Outcomes & Findings for A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction (NCT NCT05478603)
NCT ID: NCT05478603
Last Updated: 2024-08-22
Results Overview
Cmax is the maximum plasma concentration.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
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
Results posted on
2024-08-22
Participant Flow
A total of 39 participants were screened, of whom 24 participants were assigned to treatment and treated, with 6 participants in each group (without hepatic impairment, with mild hepatic impairment, with moderate hepatic impairment, and with severe hepatic impairment).
Participant milestones
| Measure |
Without Hepatic Impairment
This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1.
|
Mild Hepatic Impairment
This arm included participants with mild hepatic impairment who received PF-07081532 20mg on Day 1.
|
Moderate Hepatic Impairment
This arm included participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1.
|
Severe Hepatic Impairment
This arm included participants with severe hepatic impairment who received PF-07081532 20mg on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Without Hepatic Impairment
This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1.
|
Mild Hepatic Impairment
This arm included participants with mild hepatic impairment who received PF-07081532 20mg on Day 1.
|
Moderate Hepatic Impairment
This arm included participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1.
|
Severe Hepatic Impairment
This arm included participants with severe hepatic impairment who received PF-07081532 20mg on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Understand How the Study Medicine (PF-07081532) is Processed in People With Liver Dysfunction
Baseline characteristics by cohort
| Measure |
Without Hepatic Impairment
n=6 Participants
This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1.
|
Mild Hepatic Impairment
n=6 Participants
This arm included participants with mild hepatic impairment who received PF-07081532 20mg on Day 1.
|
Moderate Hepatic Impairment
n=6 Participants
This arm included participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1.
|
Severe Hepatic Impairment
n=6 Participants
This arm included participants with severe hepatic impairment who received PF-07081532 20mg on Day 1.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
18-44 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Customized
45-64 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
Cmax is the maximum plasma concentration.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of PF-07081532
|
2236 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 10
|
2121 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
2230 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 30
|
1536 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 49
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
AUCinf is the area under the plasma concentration-time profile from time zero extrapolated to infinite time.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-07081532
|
43200 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
44010 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 61
|
67430 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 66
|
41680 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
AUClast is the area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg 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
|
40990 ng*hr/mL
Geometric Coefficient of Variation 39
|
41900 ng*hr/mL
Geometric Coefficient of Variation 63
|
62680 ng*hr/mL
Geometric Coefficient of Variation 64
|
39800 ng*hr/mL
Geometric Coefficient of Variation 63
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
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).
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Fraction of Unbound Drug in Plasma (Fu) of PF-07081532
|
0.0002753 Ratio
Geometric Coefficient of Variation 12
|
0.0002568 Ratio
Geometric Coefficient of Variation 38
|
0.0002937 Ratio
Geometric Coefficient of Variation 19
|
0.0006780 Ratio
Geometric Coefficient of Variation 66
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
Cmax,u is the unbound Cmax.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Unbound Cmax (Cmax,u) of PF-07081532
|
0.6156 ng/mL
Geometric Coefficient of Variation 17
|
0.5448 ng/mL
Geometric Coefficient of Variation 42
|
0.6551 ng/mL
Geometric Coefficient of Variation 36
|
1.042 ng/mL
Geometric Coefficient of Variation 34
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
AUCinf,u is the unbound AUCinf.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Unbound AUCinf (AUCinf,u) of PF-07081532
|
11.88 ng*hr/mL
Geometric Coefficient of Variation 29
|
11.30 ng*hr/mL
Geometric Coefficient of Variation 91
|
19.81 ng*hr/mL
Geometric Coefficient of Variation 68
|
28.24 ng*hr/mL
Geometric Coefficient of Variation 65
|
PRIMARY outcome
Timeframe: 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 1Population: 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.
AUClast,u is the unbound AUClast.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Unbound AUClast (AUClast,u) of PF-07081532
|
11.29 ng*hr/mL
Geometric Coefficient of Variation 29
|
10.76 ng*hr/mL
Geometric Coefficient of Variation 94
|
18.41 ng*hr/mL
Geometric Coefficient of Variation 66
|
27.02 ng*hr/mL
Geometric Coefficient of Variation 64
|
SECONDARY outcome
Timeframe: Day 1 to Day 36Population: The safety analysis set included all participants who each took 1 dose of PF-07081532.
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.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
All-causality TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Treatment-related TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From baseline (BL) to Day 7Population: The safety analysis set included all participants who each took 1 dose of PF-07081532. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Safety laboratory assessments included clinical chemistry, hematology, and urinalysis tests. Number of participants with clinical laboratory abnormalities meeting pre-specified criteria is reported.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Hemoglobin (gram per deciliter [g/dL]) <0.8*lower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Hematocrit (%) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Erythrocytes (10^12/liter [L]) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Volume (femtoliter [fL]) >1.1*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Ery. Mean Corpuscular Hemoglobin (picogram/cell [pg/cell]) <0.9*LLN
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Platelets (10^9/L) <0.5*LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Neutrophils (10^9/L) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Basophils/Leukocytes (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Eosinophils/Leukocytes (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Monocytes/Leukocytes (%) >1.2*ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Activated Partial Thromboplastin Time (second [sec]) >1.1*ULN
|
2 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Prothrombin Time (sec) >1.1*ULN
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Prothrombin International Normalized Ratio >1.1*ULN
|
0 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Bilirubin (milligram per deciliter [mg/dL]) >1.5*ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Direct Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Indirect Bilirubin (mg/dL) >1.5*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Aspartate Aminotransferase (unit per liter [U/L]) >3.0*ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Gamma Glutamyl Transferase (U/L) >3.0*ULN
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Albumin (g/dL) <0.8*LLN
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Urate (mg/dL) >1.2*ULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Ketones ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
URINE Hemoglobin ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Urobilinogen ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
URINE Bilirubin ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Leukocyte Esterase ≥1
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Epithelial Cells (/low-power field [LPF]) ≥6
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From BL to Day 7Population: The safety analysis set included all participants who each took 1 dose of PF-07081532.
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.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Diastolic BP Value <50mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Diastolic BP Increase ≥20mmHg
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Diastolic BP Decrease ≥20mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Pulse Rate Value <40bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Pulse Rate Value >120bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Systolic BP Value <90mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Systolic BP Increase ≥30mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria
Systolic BP Decrease ≥30mmHg
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From BL to Day 7Population: The safety analysis set included all participants who each took 1 dose of PF-07081532.
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.
Outcome measures
| Measure |
Without Hepatic Impairment
n=6 Participants
Participants without hepatic impairment who received PF-07081532 20mg on Day 1
|
Mild Hepatic Impairment
n=6 Participants
Participants with mild hepatic impairment who received PF-07081532 20mg on Day 1
|
Moderate Hepatic Impairment
n=6 Participants
Participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1
|
Severe Hepatic Impairment
n=6 Participants
Participants with severe hepatic impairment who received PF-07081532 20mg on Day 1
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF Change > 60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
PR Interval %Change ≥ 25/50% msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QRS Interval Value ≥ 140 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QRS Interval %Change ≥ 50% msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF 450 < Value ≤ 480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF 480 < Value ≤ 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF Value > 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
QTcF 30 < Change ≤ 60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria
PR Interval Value ≥ 300 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Without Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mild Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Severe Hepatic Impairment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Without Hepatic Impairment
n=6 participants at risk
This arm included participants without hepatic impairment who received PF-07081532 20mg on Day 1.
|
Mild Hepatic Impairment
n=6 participants at risk
This arm included participants with mild hepatic impairment who received PF-07081532 20mg on Day 1.
|
Moderate Hepatic Impairment
n=6 participants at risk
This arm included participants with moderate hepatic impairment who received PF-07081532 20mg on Day 1.
|
Severe Hepatic Impairment
n=6 participants at risk
This arm included participants with severe hepatic impairment who received PF-07081532 20mg on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
0.00%
0/6 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
16.7%
1/6 • Number of events 1 • Day 1 to Day 36
SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. Total number at risk below refers to the number of participants evaluable for SAEs/AEs. Unless otherwise noted, all treatment-emergent, all-causality events are reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER