Healthy Volunteers, Hepatic Impairment
Conditions
Keywords
Non-alcoholic Fatty Liver Disease, Non-alcoholic steatohepatitis
Brief summary
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
Interventions
DRUGPF-06865571 100 mg
PF-06865571 in 100 mg oral tablet will be administered on Day 1
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Body mass index (BMI) of 17.5 to 35.4 kg/m2, inclusive; and a total body weight \>50 kg (110 lb), at the Screening visit; with a single repeat assessment of total body weight (and hence BMI), on a separate day permitted to assess eligibility, if needed. * Capable of giving signed informed consent.
Exclusion criteria
* Any condition possibly affecting drug absorption (eg, prior bariatric surgery,gastrectomy, ileal resection). * At Screening, participants with a positive result for human immunodeficiency virus (HIV) antibodies, as assessed by sponsor-identified central laboratory, with a single repeat permitted to assess eligibility, if needed. * Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer). * Participants with known prior participation (ie, randomized and received at least 1 dose of investigational product) in a study involving PF-06865571. * A positive urine drug test, for illicit drugs on Day -1, * At Screening or Day -1, a positive breath alcohol test. * Male participants with partners who are currently pregnant. * Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing and until the follow-up contact. * Unwilling or unable to comply with the criteria in the Lifestyle Considerations. * Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | 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. | Cmax of PF-06865571 was observed directly from data. |
| Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast) | 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. | AUClast of PF-06865571 was determined by linear/log trapezoidal method. |
| Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf) | 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. | AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 32 (31 days after investigational product administration) | 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. |
| Number of Participants With Categorical Electrocardiogram (ECG) | Up to Day 4 (3 days after investigational product administration) | 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. |
| Number of Participants With Clinical Laboratory Abnormalities | Up to Day 4 (3 days after investigational product administration) | The following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here. |
| Number of Participants With Categorical Vital Signs Data | Up to Day 4 (3 days after investigational product administration) | Vital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (Without Hepatic Impairment) Hepatic function was categorized based on Child Pugh Score.
NA for participants without hepatic impairment. | 6 |
| 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. | 6 |
| 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. | 6 |
| 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. | 6 |
| Total | 24 |
Baseline characteristics
| Characteristic | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 3.92 | 58.2 years STANDARD_DEVIATION 5.15 | 64.5 years STANDARD_DEVIATION 5.32 | 57.5 years STANDARD_DEVIATION 8.6 | 60.3 years STANDARD_DEVIATION 6.26 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 3 Participants | 3 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 6 Participants | 4 Participants | 22 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 0 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 6 Participants | 3 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Without Hepatic Impairment) | Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf) | 2083 ng*hr/mL | Geometric Coefficient of Variation 155 |
| Cohort 2 (Mild Hepatic Impairment) | Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf) | 3250 ng*hr/mL | Geometric Coefficient of Variation 39 |
| Cohort 3 (Moderate Hepatic Impairment) | Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf) | 3445 ng*hr/mL | Geometric Coefficient of Variation 42 |
| Cohort 4 (Severe Hepatic Impairment) | Area Under the Curve From Time 0 to Extrapolated Infinite Time (AUCinf) | 3171 ng*hr/mL | Geometric Coefficient of Variation 47 |
90% CI: [80.95, 300.6]
90% CI: [85.82, 318.67]
90% CI: [78.99, 293.29]
Primary
Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast)
AUClast of PF-06865571 was determined by linear/log trapezoidal method.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Without 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 |
| Cohort 2 (Mild Hepatic Impairment) | Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast) | 3247 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 40 |
| Cohort 3 (Moderate Hepatic Impairment) | Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast) | 3443 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 42 |
| Cohort 4 (Severe Hepatic Impairment) | Area Under the Curve From Time 0 to Last Quantifiable Concentration (AUClast) | 3163 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 47 |
90% CI: [81.07, 301.16]
90% CI: [85.95, 319.29]
90% CI: [78.96, 293.32]
Primary
Maximum Observed Plasma Concentration (Cmax)
Cmax of PF-06865571 was observed directly from data.
Time frame: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Without Hepatic Impairment) | Maximum Observed Plasma Concentration (Cmax) | 532.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 153 |
| Cohort 2 (Mild Hepatic Impairment) | Maximum Observed Plasma Concentration (Cmax) | 835.5 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
| Cohort 3 (Moderate Hepatic Impairment) | Maximum Observed Plasma Concentration (Cmax) | 668.3 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 35 |
| Cohort 4 (Severe Hepatic Impairment) | Maximum Observed Plasma Concentration (Cmax) | 658.6 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 42 |
90% CI: [83.14, 296.44]
90% CI: [66.51, 237.13]
90% CI: [65.54, 233.68]
Secondary
Number of Participants With Categorical Electrocardiogram (ECG)
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.
Time frame: Up to Day 4 (3 days after investigational product administration)
Population: All participants who received PF-06865571.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 30<= Change <=60 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 480< Value <=500 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Change >60 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Value >500 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (millisecond [msec]) 450< Value <=480 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Value >500 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 30<= Change <=60 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Change >60 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 480< Value <=500 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (millisecond [msec]) 450< Value <=480 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Value >500 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (millisecond [msec]) 450< Value <=480 | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 480< Value <=500 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 30<= Change <=60 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Change >60 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 30<= Change <=60 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) 480< Value <=500 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (millisecond [msec]) 450< Value <=480 | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Value >500 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Electrocardiogram (ECG) | QTcF (msec) Change >60 | 0 Participants |
Secondary
Number of Participants With Categorical Vital Signs Data
Vital signs (systolic and diastolic blood pressure, and pulse rate) were obtained with participants after having sat calmly for at least 5 minutes.
Time frame: Up to Day 4 (3 days after investigational product administration)
Population: All participants who received PF-06865571.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg increase | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg decrease | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Value <50 mmHg | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (bpm) Value >120 bpm | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (beats per minute [bpm]) Value <40 bpm | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg decrease | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Value <90 mmHg | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg increase | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (bpm) Value >120 bpm | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg increase | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg decrease | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg decrease | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Value <50 mmHg | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Value <90 mmHg | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (beats per minute [bpm]) Value <40 bpm | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg increase | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg decrease | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (beats per minute [bpm]) Value <40 bpm | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (bpm) Value >120 bpm | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Value <90 mmHg | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg increase | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg decrease | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Value <50 mmHg | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg increase | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Value <50 mmHg | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg increase | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Value <90 mmHg | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg decrease | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Diastolic Blood Pressure (mmHg) Change >=20 mmHg increase | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (bpm) Value >120 bpm | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Systolic Blood Pressure (mmHg) Change >=30 mmHg decrease | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Categorical Vital Signs Data | Pulse Rate (beats per minute [bpm]) Value <40 bpm | 0 Participants |
Secondary
Number of Participants With Clinical Laboratory Abnormalities
The following parameters were analyzed for laboratory examination: hematology, clinical chemistry, and urinalysis. The abnormalities with at least 1 participant are presented here.
Time frame: Up to Day 4 (3 days after investigational product administration)
Population: All participants who received PF-06865571.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Glucose ≥1 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hemoglobin <0.8xLower limit of normal (LLN) | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hematocrit <0.8xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Erythrocytes (Ery.) <0.8xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume <0.9xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume >1.1xupper limit of normal (ULN) | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin <0.9xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin >1.1xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Platelets <0.5xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Leukocytes <0.6xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes <0.8xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Neutrophils <0.8xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Monocytes >1.2xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time >1.1xULN | 1 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin Time >1.1xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin International. Normalized Ratio >1.1xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Bilirubin >1.5xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Direct Bilirubin >1.5xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Nitrite ≥1 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Indirect Bilirubin >1.5xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase >3.0xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase >3.0xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Gamma Glutamyl Transferase >3.0xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Albumin <0.8xLLN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Glucose >1.5xULN | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Ketones ≥1 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Protein ≥1 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Hemoglobin ≥1 | 2 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Urobilinogen ≥1 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bilirubin ≥1 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Leukocytes ≥20 | 0 Participants |
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bacteria >20 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Platelets <0.5xLLN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Glucose >1.5xULN | 2 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Direct Bilirubin >1.5xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume >1.1xupper limit of normal (ULN) | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Albumin <0.8xLLN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bacteria >20 | 1 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Indirect Bilirubin >1.5xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Hemoglobin ≥1 | 1 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Monocytes >1.2xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Gamma Glutamyl Transferase >3.0xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase >3.0xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bilirubin ≥1 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase >3.0xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Protein ≥1 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Nitrite ≥1 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume <0.9xLLN | 1 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes <0.8xLLN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time >1.1xULN | 1 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Leukocytes <0.6xLLN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Ketones ≥1 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Erythrocytes (Ery.) <0.8xLLN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin Time >1.1xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin >1.1xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Leukocytes ≥20 | 1 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hematocrit <0.8xLLN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin International. Normalized Ratio >1.1xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin <0.9xLLN | 1 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hemoglobin <0.8xLower limit of normal (LLN) | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Urobilinogen ≥1 | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Bilirubin >1.5xULN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Neutrophils <0.8xLLN | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Glucose ≥1 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Protein ≥1 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Leukocytes <0.6xLLN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes <0.8xLLN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Neutrophils <0.8xLLN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Monocytes >1.2xULN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Hemoglobin ≥1 | 2 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time >1.1xULN | 2 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin Time >1.1xULN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin International. Normalized Ratio >1.1xULN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Bilirubin >1.5xULN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Urobilinogen ≥1 | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Direct Bilirubin >1.5xULN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Indirect Bilirubin >1.5xULN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bilirubin ≥1 | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase >3.0xULN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase >3.0xULN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Nitrite ≥1 | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Gamma Glutamyl Transferase >3.0xULN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Albumin <0.8xLLN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bacteria >20 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Glucose >1.5xULN | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hematocrit <0.8xLLN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Glucose ≥1 | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hemoglobin <0.8xLower limit of normal (LLN) | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Erythrocytes (Ery.) <0.8xLLN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume <0.9xLLN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Ketones ≥1 | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume >1.1xupper limit of normal (ULN) | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin <0.9xLLN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Leukocytes ≥20 | 1 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin >1.1xULN | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Platelets <0.5xLLN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Bilirubin >1.5xULN | 4 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hematocrit <0.8xLLN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Protein ≥1 | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin International. Normalized Ratio >1.1xULN | 3 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin <0.9xLLN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Hemoglobin <0.8xLower limit of normal (LLN) | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Glucose ≥1 | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bacteria >20 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Prothrombin Time >1.1xULN | 3 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Hemoglobin ≥1 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Leukocytes <0.6xLLN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Erythrocytes (Ery.) <0.8xLLN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Activated Partial Thromboplastin Time >1.1xULN | 2 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Monocytes >1.2xULN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Lymphocytes <0.8xLLN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Aspartate Aminotransferase >3.0xULN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Indirect Bilirubin >1.5xULN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume <0.9xLLN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Alanine Aminotransferase >3.0xULN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Platelets <0.5xLLN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Bilirubin ≥1 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Neutrophils <0.8xLLN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Gamma Glutamyl Transferase >3.0xULN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Nitrite ≥1 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Direct Bilirubin >1.5xULN | 4 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Hemoglobin >1.1xULN | 2 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Albumin <0.8xLLN | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Ery. Mean Corpuscular Volume >1.1xupper limit of normal (ULN) | 1 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Urobilinogen ≥1 | 2 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Ketones ≥1 | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Glucose >1.5xULN | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Clinical Laboratory Abnormalities | Urine Leukocytes ≥20 | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: Up to Day 32 (31 days after investigational product administration)
Population: All participants who received PF-06865571.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Without Hepatic Impairment) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| Cohort 2 (Mild Hepatic Impairment) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| Cohort 3 (Moderate Hepatic Impairment) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| Cohort 4 (Severe Hepatic Impairment) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |