PF-06865571 100 mg
DrugPF-06865571 in 100 mg oral tablet will be administered on Day 1
NCT Number: NCT04091061
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 1
University of Miami Division of Clinical Pharmacology, Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PF-06865571 in 100 mg oral tablet will be administered on Day 1
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.
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.
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.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Pfizer
Industry
A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-COHORT STUDY TO COMPARE THE PHARMACOKINETICS OF PF 06865571 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05917938
Healthy Volunteers, Hepatic Impairment
München, Germany
View Trial DetailsNCT06535399
Digestive System Diseases, Healthy Volunteers
Chandler, Arizona, United States
View Trial DetailsNCT05564104
Healthy Volunteers, Hepatic Impairment
Prague, Czechia
View Trial DetailsNCT06052566
Digestive System Diseases, Fatty Liver
Miami, Florida, United States
View Trial Details