This is a Phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the PK, safety and tolerability of PF 04965842.
A minimum of 24 subjects with normal, mild or moderate hepatic function will be enrolled into the study, with approximately 8 subjects in each cohort. The Child Pugh classification score will be utilized to assess entry criteria and to assign subjects into the appropriate hepatic impairment group. For individual subjects, the total maximum duration of study participation from the Screening visit to the end of clinical research unit (CRU) stay is approximately 31 days and approximately 63 days from the Screening visit to the Follow up contact.
Study Type
INTERVENTIONAL
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
Orlando Clinical Research Center
Orlando, Florida, United States
Prism Clinical Research, LLC
Saint Paul, Minnesota, United States
Maximum Observed Plasma Concentration (Cmax) for PF-04965842
Cmax is maximum plasma concentration. It was observed directly from data.
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-04965842
AUCinf is area under the concentration-time curve (AUC) from time 0 (pre-dose) extrapolated to infinite time.
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort
Number of Participants With Treatment-Emergent Adverse Events (AEs) for PF-04965842
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent adverse events (TEAEs) were those with initial onset or increasing in severity between the first dose of investigational product and up to 36 days post-dose.
Time frame: From screening (within 28 days prior to Day 1) till up to 36 days post-dose, the total maximum duration was approximately 63 days for individual participants.
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
Laboratory tests included tests that were performed under the categories of hematology, chemistry, urinalysis, other, and additional tests needed for Hy's law.
Time frame: Screening (within 28 days prior to Day 1), Day -1, 2, 24, 72 hours post-dose.
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance for PF-04965842
12-Lead ECGs were collected after the participants rested quietly for at least 10 minutes in a supine position. Clinical significance of ECG recordings was determined at the investigator's discretion.
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Time frame: Screening (within 28 days prior to Day 1), Day -1, 2, 72 hours post-dose.
Number of Participants With Vital Sign Findings of Potential Clinical Importance for PF-04965842
Vital signs (pulse rate, systolic and diastolic blood pressure) were obtained with participant following at least 5 minutes of supine rest. Clinical significance of vital signs was determined at the investigator's discretion.
Time frame: Screening (within 28 days prior to Day 1), 0 (pre-dose), and 72 hours post-dose.