Trial Outcomes & Findings for Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332 (NCT NCT05005312)
NCT ID: NCT05005312
Last Updated: 2023-09-06
Results Overview
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation was expressed in percentage.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
17 participants
Primary outcome timeframe
Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hours
Results posted on
2023-09-06
Participant Flow
Seventeen participants were assigned to treatment. One participant in the moderate hepatic impairment group was excluded from the safety and pharmacokinetic (PK) analysis set as this participant was randomized but was discontinued on Day 1 prior to dosing with study treatment PF-07321332. All 16 treated participants included 8 participants without hepatic impairment (Cohort 1) and 8 participants with moderate hepatic impairment (Cohort 2) completed the study.,
Participant milestones
| Measure |
Normal Hepatic Function
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
|
Overall Study
Treated
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Normal Hepatic Function
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Overall Study
Enrolled, but not treated
|
0
|
1
|
Baseline Characteristics
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Baseline characteristics by cohort
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 Years
STANDARD_DEVIATION 6.16 • n=99 Participants
|
56.1 Years
STANDARD_DEVIATION 9.33 • n=107 Participants
|
54.4 Years
STANDARD_DEVIATION 7.83 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hoursPopulation: The PK parameter analysis population was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
Cmax was the maximum observed plasma concentration and was directly observed from data. Concentration values below the lower limit of quantification (LLQ) were set to zero. Geometric mean analysis was on the log scale. Zero values were not included in geometric mean and geometric coefficient of variation calculation. The geometric coefficient of variation was expressed in percentage.
Outcome measures
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Plasma PF-07321332
|
1.886 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 20
|
1.923 micrograms per milliliter (ug/mL)
Geometric Coefficient of Variation 48
|
PRIMARY outcome
Timeframe: Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hoursPopulation: The PK parameter analysis population was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration. The geometric coefficient of variation was expressed in percentage.
Outcome measures
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of Plasma PF-07321332
|
14.97 micrograms/milliliter/hour (ug*hr/mL)
Geometric Coefficient of Variation 36
|
14.86 micrograms/milliliter/hour (ug*hr/mL)
Geometric Coefficient of Variation 43
|
PRIMARY outcome
Timeframe: Day 1 at 0 (pre-dose for PF-07321332), 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours, Day 2 at 24 and 36 hours, and Day 3 at 48 hoursPopulation: The PK parameter analysis population was defined as all participants assigned to investigational product and treated who had at least 1 of the PK parameters of primary interest measured.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity. The geometric coefficient of variation was expressed in percentage.
Outcome measures
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Plasma PF-07321332
|
15.24 ug*hr/mL
Geometric Coefficient of Variation 36
|
15.06 ug*hr/mL
Geometric Coefficient of Variation 43
|
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: Population analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse event (TEAE) means event between first dose of study treatment and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. An SAE was an AE resulting in any of death; inpatient hospitalization; life-threatening experience; disability; congenital anomaly or deemed significant for any other reason.
Outcome measures
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Number of Participants With an Treatment Emergent Adverse Event (TEAE)
Participants with adverse events (All Causalities)
|
3 Participants
|
4 Participants
|
|
Number of Participants With an Treatment Emergent Adverse Event (TEAE)
Participants with adverse events (Treatment Related)
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: Population analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2\. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline.
Outcome measures
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Change ≥ 25/50%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 140
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QRS INTERVAL NOT OTHERWISE SPECIFIED (MSEC): %Change ≥ 50%
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QT INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value > 500
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTC INTERVAL NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTC INTERVAL NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTC INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value > 500
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTC INTERVAL NOT OTHERWISE SPECIFIED (MSEC): 30 < Change ≤ 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTC INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Change > 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF - FRIDERICIA'S CORRECTION FORMULA NOT OTHERWISE SPECIFIED (MSEC): 450 < Value ≤ 480
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF - FRIDERICIA'S CORRECTION FORMULA NOT OTHERWISE SPECIFIED (MSEC): 480 < Value ≤ 500
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF - FRIDERICIA'S CORRECTION FORMULA NOT OTHERWISE SPECIFIED (MSEC): Value > 500
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF - FRIDERICIA'S CORRECTION FORMULA NOT OTHERWISE SPECIFIED (MSEC): 30 < Change ≤ 60
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
PR INTERVAL NOT OTHERWISE SPECIFIED (MSEC): Value ≥ 300
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Electrocardiograms (ECGs)
QTCF - FRIDERICIA'S CORRECTION FORMULA NOT OTHERWISE SPECIFIED (MSEC): Change > 60
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: Population analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Criteria for vital signs abnormalities: increase or decrease from baseline in systolic blood pressure (SBP) \>=30 mm Hg and increase or decrease from baseline in diastolic blood pressure (DBP) \>=20 mm Hg; the value of SBP \<90 mm Hg; the value of DBP \<50 mm Hg; the value of pulse rate \<40 bpm or \>120 bpm.
Outcome measures
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Number of Participants With Abnormal Vital Signs
SBP: Change >= 30 mmHg decrease from baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
DBP: Value <50 mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
DBP: Change >= 20 mmHg increase from baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
DBP: Change >= 20 mmHg decrease from baseline
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Pulse Rate: Value <40 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
Pulse Rate: Value >120 bpm
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
SBP: Value <90mmHg
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Vital Signs
SBP: Change >= 30 mmHg increase from baseline
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 monthsPopulation: Population analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology; clinical chemistry; urinalysis.
Outcome measures
| Measure |
Normal Hepatic Function
n=8 Participants
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 Participants
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
URINALYSIS: URINE Hemoglobin ≥1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
URINALYSIS: Urobilinogen ≥1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
URINALYSIS: Leukocyte Esterase ≥1
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
URINALYSIS: Urine Microscopic Exam ≥1
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
HEMATOLOGY: Platelets (10^3/mm^3) <0.5× lower limit of normal (LLN)
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
HEMATOLOGY: Eosinophils (10^3/mm^3) >1.2× upper limit of normal (ULN)
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
HEMATOLOGY: Monocytes (10^3/mm^3) >1.2× ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
CLINICAL CHEMISTRY: Direct Bilirubin (mg/dL) >1.5× ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
CLINICAL CHEMISTRY: Aspartate Aminotransferase (U/L) >3.0× ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
CLINICAL CHEMISTRY: Calcium (mg/dL) >1.1× ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormal Laboratory Assessments (Without Regard to Baseline Abnormality)
CLINICAL CHEMISTRY: Glucose (mg/dL) >1.5× ULN
|
0 Participants
|
1 Participants
|
Adverse Events
Normal Hepatic Function
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Moderate Hepatic Impairment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Hepatic Function
n=8 participants at risk
Participants with normal hepatic function and matched, by average age, weight, and gender as much as practically possible with participants with moderate hepatic impairment. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
Moderate Hepatic Impairment
n=8 participants at risk
Moderate Hepatic Impairment: Participants with moderate hepatic impairment (grade B) with a Child-Pugh Score of 7-9. The CP classification assesses 5 hepatic parameters (serum total bilirubin, serum albumin, prothrombin time prolongation, ascites, and encephalopathy grade) on a scale of 1 to 3 (most severe derangement). Total moderate hepatic impairment score range is 7 to 9. Participants received single 100 mg dose of PF-07321332 administered orally in combination with the PK boosting agent ritonavir administered as a 100 mg dose at -12, 0, 12, and 24 hours relative to PF-07321332 dosing.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
General disorders
Injection site pruritus
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
25.0%
2/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
12.5%
1/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
0.00%
0/8 • From the first dose of study treatment to the last dose of study treatment date +35 days (up to 2 months)
The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
|
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