A Phase 1 interventional study of PF-05221304 in Hepatic Impairment, sponsored by Pfizer. Completed at 6 sites in 4 countries. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-08.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
Hepatic impairment PK study
This is a non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of varying degrees of hepatic impairment on the plasma pharmacokinetics (total and unbound) of PF-05221304 after a single oral dose administered in the fed state.
Key Exclusion Criteria:
All subjects -
Healthy/ those without hepatic impairment -
Those with varying degrees of hepatic impairment -
Single, 25 mg dose of PF-05221304
Drug: PF-05221304
Single, 25 mg dose of PF-05221304
Drug: PF-05221304
Single, 25 mg dose of PF-05221304
Drug: PF-05221304
Single, 25 mg dose of PF-05221304
Drug: PF-05221304
25 mg dose
Also known as: experimental drug
Maximum Plasma Concentration (Cmax) of PF-05221304
Cmax was observed directly from data.
Time frame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05221304
AUCinf was calculated by AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
Fraction Unbound (fu) of PF-05221304
fu was the fraction of PF-05221304 unbound in plasma. fu was calculated based on the post-dialysis plasma concentrations, post-dialysis buffer concentrations, collected post-dialysis plasma and post-dialysis buffer sample volume (assuming no volume shift prior to and after dialysis), and the total plasma concentrations.
Time frame: 4 hours postdose
Unbound Cmax (Cmax,u) of PF-05221304
Cmax,u was calculated by fu\*Cmax.
Time frame: 4 hours postdose
Unbound AUCinf (AUCinf,u) of PF-05221304
AUCinf,u was calculated by fu\*AUCinf.
Time frame: 4 hours postdose
Time to Reach Maximum Plasma Concentration (Tmax) of PF-05221304
Tmax was observed directly from data as time of first occurrence.
Time frame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
Area Under Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of PF-05221304
AUClast was calculated by linear/Log trapezoidal method.
Time frame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
Unbound AUClast ( AUClast,u) of PF-05221304
AUClast,u was calculated by fu\*AUClast.
Time frame: 4 hours postdose
Apparent Clearance After Oral Dose (CL/F) of PF-05221304
CL/F was calculated by Dose/AUCinf.
Time frame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
Unbound CL/F (CLu/F) of PF-05221304
CLu/F was calculated by fu\*CL/F.
Time frame: 4 hours postdose
Apparent Volume of Distribution After Oral Dose (Vz/F) of PF-05221304
Vz/F was calculated by Dose/(AUCinf\*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
Unbound Vz/F (Vz,u/F) of PF-05221304
Vz,u/F was calculated by fu\*Vz/F.
Time frame: 4 hours postdose
Terminal Half-Life ( t½) of PF-05221304
t1/2 was calculated by loge(2)/kel.
Time frame: 0, 1, 2, 3, 4, 5, 8, 10, 16, 24, 36, 48, 72, 96, 120, 144 hours postdose
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event did not need to have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Number of participants with both all-causality and treatment-related TEAEs are presented below.
Time frame: Approximately 30 days
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Hematology
Hematology evaluation included: hemoglobin, hematocrit, erythrocytes, reticulocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin concentration (MCHC), erythrocyte mean corpuscular hemoglobin, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time and prothrombin time.
Time frame: 7 days
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Clinical Chemistry
Clinical chemistry evaluation included: bilirubin, direct/indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase , alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, phosphate, bicarbonate, creatine kinase, and fasting glucose.
Time frame: 7 days
Number of Paticipants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)-Urinalysis
Urinalysis evaluation included: scalar urine glucose, scalar ketones, scalar urine protein, scalar urine hemoglobin, scalar urobilinogen, scalar urine bilirubin, scalar nitrite, scalar leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, and scalar bacteria.
Time frame: 7 days
Number of Participants With Clinical Significant Findings in Vital Signs
Vital signs evaluation included: sitting systolic and diastolic blood pressure (BP), and sitting pulse rate. Clinically significant findings in vital signs were determined by the investigator.
Time frame: 7 days
Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Data
ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate using Fridericia's formula (QTcF interval), and heart rate. Clinically significant findings in ECG data were determined by the investigator.
Time frame: 7 days
Recruitment for participants in Cohorts 3 and 4 initiated first and recruitment for participants in Cohort 2 started when approximately 50% of total participants across Cohorts 3 and 4 had been dosed. Participants in Cohort 1 were recruited last to match the average demographics across the pooled Cohorts 2 through 4.
| Milestone | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Started | 6 | 6 | 6 | 6 |
| Completed | 5 | 6 | 6 | 6 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
Cmax was observed directly from data.
| Nanogram per milliliter (ng/mL) | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of PF-05221304 | 1220 ± 20 | 1591 ± 33 | 1433 ± 20 | 1592 ± 27 |
AUCinf was calculated by AUClast + (Clast\*/kel), where AUClast was the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| Nanogram*hour per milliliter (ng*hr/mL) | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-05221304 | 17520 ± 36 | 23890 ± 41 | 21770 ± 31 | 20790 ± 43 |
fu was the fraction of PF-05221304 unbound in plasma. fu was calculated based on the post-dialysis plasma concentrations, post-dialysis buffer concentrations, collected post-dialysis plasma and post-dialysis buffer sample volume (assuming no volume shift prior to and after dialysis), and the total plasma concentrations.
| Ratio | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Fraction Unbound (fu) of PF-05221304 | 0.005519 ± 44 | 0.006883 ± 55 | 0.008117 ± 45 | 0.01240 ± 26 |
Cmax,u was calculated by fu\*Cmax.
| ng/mL | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Unbound Cmax (Cmax,u) of PF-05221304 | 6.731 ± 57 | 10.94 ± 44 | 11.63 ± 48 | 19.74 ± 43 |
AUCinf,u was calculated by fu\*AUCinf.
| ng*hr/mL | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Unbound AUCinf (AUCinf,u) of PF-05221304 | 96.78 ± 75 | 164.4 ± 34 | 176.6 ± 51 | 257.7 ± 45 |
Tmax was observed directly from data as time of first occurrence.
| Hours | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) of PF-05221304 | 4.01 (1.98 to 4.93) | 4.95 (2.95 to 5.00) | 4.50 (1.02 to 5.02) | 4.00 (0.917 to 5.00) |
AUClast was calculated by linear/Log trapezoidal method.
| ng*hr/mL | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Area Under Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of PF-05221304 | 17400 ± 36 | 23670 ± 40 | 21680 ± 31 | 20700 ± 43 |
AUClast,u was calculated by fu\*AUClast.
| ng*hr/mL | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Unbound AUClast ( AUClast,u) of PF-05221304 | 96.07 ± 75 | 163.3 ± 34 | 175.9 ± 51 | 256.7 ± 45 |
CL/F was calculated by Dose/AUCinf.
| Liter per hour (L/hr) | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Apparent Clearance After Oral Dose (CL/F) of PF-05221304 | 1.427 ± 36 | 1.048 ± 41 | 1.151 ± 31 | 1.202 ± 43 |
CLu/F was calculated by fu\*CL/F.
| L/hr | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Unbound CL/F (CLu/F) of PF-05221304 | 258.7 ± 75 | 152.0 ± 33 | 141.6 ± 51 | 97.02 ± 45 |
Vz/F was calculated by Dose/(AUCinf\*kel). kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| Liters | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Apparent Volume of Distribution After Oral Dose (Vz/F) of PF-05221304 | 34.94 ± 35 | 24.53 ± 24 | 23.16 ± 28 | 23.97 ± 23 |
Vz,u/F was calculated by fu\*Vz/F.
| Liters | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Unbound Vz/F (Vz,u/F) of PF-05221304 | 6334 ± 69 | 3563 ± 51 | 2854 ± 59 | 1931 ± 37 |
t1/2 was calculated by loge(2)/kel.
| Hours | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Terminal Half-Life ( t½) of PF-05221304 | 17.43 ± 4.7471 | 17.25 ± 6.8372 | 14.30 ± 3.4135 | 14.76 ± 5.7937 |
An adverse event (AE) was any untoward medical occurrence in a study participant administered a product or medical device; the event did not need to have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and AEs. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Number of participants with both all-causality and treatment-related TEAEs are presented below.
| Participants | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| All-causality TEAE | 0 | 1 | 2 | 0 |
| Treatment-related TEAE | 0 | 1 | 1 | 0 |
Hematology evaluation included: hemoglobin, hematocrit, erythrocytes, reticulocytes, erythrocyte mean corpuscular volume, erythrocyte mean corpuscular hemoglobin concentration (MCHC), erythrocyte mean corpuscular hemoglobin, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time and prothrombin time.
| Participants | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Hemoglobin <0.8*lower limit of normal (LLN) | 0 | 0 | 0 | 1 |
| Hematocrit <0.8*LLN | 0 | 0 | 0 | 1 |
| Erythrocytes <0.8*LLN | 0 | 0 | 1 | 1 |
| Reticulocytes <0.5*LLN | 0 | 0 | 0 | 0 |
| Reticulocytes >1.5*upper limit of normal (ULN) | 0 | 0 | 0 | 0 |
| Erythrocyte Mean Corpuscular Volume <0.9*LLN | 0 | 0 | 0 | 0 |
| Erythrocyte Mean Corpuscular Volume >1.1*ULN | 0 | 0 | 0 | 0 |
| Erythrocyte MCHC <0.9*LLN | 0 | 0 | 0 | 0 |
| Erythrocyte MCHC >1.1*ULN | 0 | 0 | 0 | 0 |
| Erythrocyte Mean Corpuscular Hemoglobin <0.9*LLN | 0 | 0 | 0 | 0 |
| Erythrocyte Mean Corpuscular Hemoglobin >1.1*ULN | 0 | 0 | 1 | 0 |
| Platelets <0.5*LLN | 0 | 0 | 3 | 2 |
| Platelets >1.75*ULN | 0 | 0 | 0 | 0 |
| Leukocytes <0.6*LLN | 0 | 0 | 0 | 0 |
| Leukocytes >1.5*ULN | 0 | 0 | 0 | 0 |
| Lymphocytes <0.8*LLN | 0 | 0 | 2 | 1 |
| Lymphocytes >1.2*ULN | 0 | 0 | 0 | 0 |
| Neutrophils <0.8*LLN | 0 | 0 | 1 | 0 |
| Neutrophils >1.2*ULN | 0 | 0 | 0 | 0 |
| Basophils >1.2*ULN | 0 | 0 | 0 | 0 |
| Eosinophils >1.2*ULN | 0 | 0 | 0 | 0 |
| Monocytes >1.2*ULN | 0 | 0 | 0 | 0 |
| Activated Partial Thromboplastin Time >1.1*ULN | 0 | 0 | 0 | 0 |
| Prothrombin Time >1.1*ULN | 0 | 0 | 1 | 3 |
Clinical chemistry evaluation included: bilirubin, direct/indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase , alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, urate, sodium, potassium, chloride, calcium, phosphate, bicarbonate, creatine kinase, and fasting glucose.
| Participants | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Bilirubin >1.5*ULN | 0 | 0 | 1 | 5 |
| Direct Bilirubin >1.5*ULN | — | 0 | 0 | 0 |
| Indirect Bilirubin >1.5*ULN | 0 | 0 | 0 | 2 |
| Aspartate Aminotransferase >3.0*ULN | 0 | 0 | 1 | 2 |
| Alanine Aminotransferase >3.0*ULN | 0 | 0 | 0 | 0 |
| Gamma Glutamyl Transferase >3.0*ULN | 0 | 1 | 0 | 2 |
| Alkaline Phosphatase >3.0*ULN | 0 | 0 | 0 | 0 |
| Protein <0.8*LLN | 0 | 0 | 0 | 0 |
| Protein >1.2*ULN | 0 | 0 | 0 | 0 |
| Albumin <0.8*LLN | 0 | 0 | 0 | 0 |
| Albumin >1.2*ULN | 0 | 0 | 0 | 0 |
| Blood Urea Nitrogen >1.3*ULN | 0 | 0 | 0 | 0 |
| Creatinine >1.3*ULN | 0 | 0 | 0 | 0 |
| Urate >1.2*ULN | 0 | 0 | 0 | 0 |
| Sodium <0.95*LLN | 0 | 0 | 0 | 0 |
| Sodium >1.05*ULN | 0 | 0 | 0 | 0 |
| Potassium <0.9*LLN | 0 | 0 | 0 | 0 |
| Potassium >1.1*ULN | 0 | 0 | 0 | 0 |
| Chloride <0.9*LLN | 0 | 0 | 0 | 0 |
| Chloride >1.1*ULN | 0 | 0 | 0 | 0 |
| Calcium <0.9*LLN | 0 | 0 | 0 | 0 |
| Calcium >1.1*ULN | 0 | 0 | 0 | 0 |
| Phosphate <0.8*LLN | 0 | 0 | 0 | 0 |
| Phosphate >1.2*ULN | 0 | 0 | 0 | 0 |
| Bicarbonate <0.9*LLN | 0 | 0 | 0 | 0 |
| Bicarbonate >1.1*ULN | 0 | 0 | 0 | 0 |
| Creatine Kinase >2.0*ULN | 0 | 0 | 0 | 0 |
| Fasting Glucose <0.6*LLN | 0 | 0 | 0 | 0 |
| Fasting-Glucose >1.5*ULN | 0 | 1 | 0 | 0 |
Urinalysis evaluation included: scalar urine glucose, scalar ketones, scalar urine protein, scalar urine hemoglobin, scalar urobilinogen, scalar urine bilirubin, scalar nitrite, scalar leukocyte esterase, urine erythrocytes, urine leukocytes, hyaline casts, and scalar bacteria.
| Participants | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Scalar Urine Glucose >=1 | 0 | 0 | 1 | 0 |
| Scalar Ketones >=1 | 0 | 0 | 0 | 0 |
| Scalar Urine Protein >=1 | 0 | 0 | 0 | 0 |
| Scalar Urine Hemoglobin >=1 | 0 | 0 | 0 | 1 |
| Scalar Urobilinogen >=1 | 0 | 0 | 1 | 3 |
| Scalar Urine Bilirubin >=1 | 0 | 0 | 0 | 0 |
| Scalar Nitrite >=1 | 1 | 0 | 0 | 0 |
| Scalar Leukocyte Esterase >=1 | 1 | 1 | 2 | 1 |
| Urine Erythrocytes >=20 (/high power field [HPF]) | 0 | — | 0 | 0 |
| Urine Leukocytes >=20 (/HPF) | 0 | 1 | 0 | 0 |
| Hyaline Casts >1 (/low power field [LPF]) | — | 1 | 1 | — |
| Scalar Bacteria >20 | 0 | 0 | 0 | 0 |
Vital signs evaluation included: sitting systolic and diastolic blood pressure (BP), and sitting pulse rate. Clinically significant findings in vital signs were determined by the investigator.
| Participants | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Number of Participants With Clinical Significant Findings in Vital Signs | 0 | 0 | 0 | 0 |
ECG evaluation included: PR interval, time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS interval), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT interval), QT interval corrected for heart rate using Fridericia's formula (QTcF interval), and heart rate. Clinically significant findings in ECG data were determined by the investigator.
| Participants | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| Number of Participants With Clinically Significant Findings in Electrocardiogram (ECG) Data | 0 | 0 | 0 | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 (Without Hepatic Impairment) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Cohort 2 (Mild Hepatic Impairment) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Cohort 3 (Moderate Hepatic Impairment) | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Cohort 4 (Severe Hepatic Impairment) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Event | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) |
|---|---|---|---|---|
| InfluenzaInfections and infestations | 0/6 | 0/6 | 1/6 | 0/6 |
| SomnolenceNervous system disorders | 0/6 | 0/6 | 1/6 | 0/6 |
| BlisterSkin and subcutaneous tissue disorders | 0/6 | 1/6 | 0/6 | 0/6 |
| Age, Categorical(Participants) | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 4 | 5 | 21 |
| >=65 years | 0 | 0 | 2 | 1 | 3 |
| Age, Continuous(Years) | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| Mean | 56.17 ± 2.23 | 55.50 ± 9.73 | 60.00 ± 5.97 | 55.33 ± 7.50 | 56.75 ± 6.74 |
| Sex: Female, Male(Participants) | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| Female | 2 | 1 | 2 | 1 | 6 |
| Male | 4 | 5 | 4 | 5 | 18 |
| Race/Ethnicity, Customized(Participants) | Cohort 1 (Without Hepatic Impairment) | Cohort 2 (Mild Hepatic Impairment) | Cohort 3 (Moderate Hepatic Impairment) | Cohort 4 (Severe Hepatic Impairment) | Total |
|---|---|---|---|---|---|
| White | 4 | 5 | 6 | 6 | 21 |
| Black or African American | 2 | 0 | 0 | 0 | 2 |
| Asian | 0 | 1 | 0 | 0 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pfizer