Trial Outcomes & Findings for Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects (NCT NCT04091061)
NCT ID: NCT04091061
Last Updated: 2021-04-13
Results Overview
Cmax of PF-06865571 was observed directly from data.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.
Results posted on
2021-04-13
Participant Flow
Of the 32 participants screened for entry into the study, 24 participants were assigned and received a single, oral 100 mg dose of PF-06865571: 6 participants in each of the 4 hepatic function cohorts.
Participant milestones
| Measure |
Cohort 1 (Without Hepatic Impairment)
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 3.92 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 5.15 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 5.32 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 8.60 • n=4 Participants
|
60.3 years
STANDARD_DEVIATION 6.26 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.Population: All participants who received PF-06865571 and in whom at least 1 plasma concentration value was reported.
Cmax of PF-06865571 was observed directly from data.
Outcome measures
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
532.2 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 153
|
835.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
668.3 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
658.6 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.Population: All participants dosed who had at least 1 of the PK parameters.
AUClast of PF-06865571 was determined by linear/log trapezoidal method.
Outcome measures
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)
|
2078 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 155
|
3247 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 40
|
3443 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42
|
3163 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
PRIMARY outcome
Timeframe: For Cohort 1, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose. For Cohorts 2-4, pre-dose, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 hours post dose.Population: All participants dosed who had at least 1 of the PK parameters.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).
Outcome measures
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)
|
2083 ng*hr/mL
Geometric Coefficient of Variation 155
|
3250 ng*hr/mL
Geometric Coefficient of Variation 39
|
3445 ng*hr/mL
Geometric Coefficient of Variation 42
|
3171 ng*hr/mL
Geometric Coefficient of Variation 47
|
SECONDARY outcome
Timeframe: Up to Day 32 (31 days after investigational product administration)Population: All participants who received PF-06865571.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who receives study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events following start of treatment.
Outcome measures
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 4 (3 days after investigational product administration)Population: All participants who received PF-06865571.
The following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here.
Outcome measures
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities
Alanine Aminotransferase >3.0xULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Glucose >1.5xULN
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Hemoglobin <0.8xLower limit of normal (LLN)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Hematocrit <0.8xLLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Erythrocytes (Ery.) <0.8xLLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Ery. Mean Corpuscular Volume <0.9xLLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Ery. Mean Corpuscular Volume >1.1xupper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Ery. Mean Corpuscular Hemoglobin <0.9xLLN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Ery. Mean Corpuscular Hemoglobin >1.1xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Platelets <0.5xLLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Leukocytes <0.6xLLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Lymphocytes <0.8xLLN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Neutrophils <0.8xLLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Monocytes >1.2xULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Activated Partial Thromboplastin Time >1.1xULN
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Prothrombin Time >1.1xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Prothrombin International. Normalized Ratio >1.1xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Bilirubin >1.5xULN
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Direct Bilirubin >1.5xULN
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Indirect Bilirubin >1.5xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Aspartate Aminotransferase >3.0xULN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Gamma Glutamyl Transferase >3.0xULN
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Albumin <0.8xLLN
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Glucose ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Ketones ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Protein ≥1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Hemoglobin ≥1
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Urobilinogen ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Bilirubin ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Nitrite ≥1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Leukocytes ≥20
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities
Urine Bacteria >20
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 4 (3 days after investigational product administration)Population: All participants who received PF-06865571.
Vital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes.
Outcome measures
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Number of Participants With Categorical Vital Signs Data
Systolic Blood Pressure (mmHg) Value <90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Data
Systolic Blood Pressure (mmHg) Change >=30 mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Data
Systolic Blood Pressure (mmHg) Change >=30 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Data
Diastolic Blood Pressure (mmHg) Value <50 mmHg
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Categorical Vital Signs Data
Diastolic Blood Pressure (mmHg) Change >=20 mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Data
Diastolic Blood Pressure (mmHg) Change >=20 mmHg decrease
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Data
Pulse Rate (beats per minute [bpm]) Value <40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Vital Signs Data
Pulse Rate (bpm) Value >120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 4 (3 days after investigational product administration)Population: All participants who received PF-06865571.
QT interval corrected using Fridericia's formula (QTcF) was obtained with participants. All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position.
Outcome measures
| Measure |
Cohort 1 (Without Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment.
|
Cohort 2 (Mild Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class A (5 to 6 points) for participants with mild hepatic impairment.
|
Cohort 3 (Moderate Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class B (7 to 9 points) for participants with moderate hepatic impairment.
|
Cohort 4 (Severe Hepatic Impairment)
n=6 Participants
Hepatic function was categorized based on Child Pugh Score.
Class C (10 to 15 points) for participants with severe hepatic impairment.
|
|---|---|---|---|---|
|
Number of Participants With Categorical Electrocardiogram (ECG)
QTcF (millisecond [msec]) 450< Value <=480
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG)
QTcF (msec) 480< Value <=500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG)
QTcF (msec) Value >500
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG)
QTcF (msec) 30<= Change <=60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Categorical Electrocardiogram (ECG)
QTcF (msec) Change >60
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Cohort 1 (Without Hepatic Impairment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2 (Mild Hepatic Impairment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 3 (Moderate Hepatic Impairment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4 (Severe Hepatic Impairment)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not 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