The purpose of this study is to evaluate the effect of moderate or severe liver impairment on the drug levels of oral azacitidine and the safety and tolerability of oral azacitidine in participants with myeloid malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
2
Specified dose on specified days
Local Institution - 0083
Iowa City, Iowa, United States
Local Institution - 0069
Detroit, Michigan, United States
AUC0-t: Estimation of area under the plasma concentration-time curve (AUC) calculated from time zero to the last measured time point
Time frame: Day 1
AUC0-∞: Estimation of AUC calculated from time zero to infinity
Time frame: Day 1
Cmax: Observed maximum concentration
Time frame: Day 1
Incidence of adverse events
Time frame: Up to 9 Months
Incidence of serious adverse events
Time frame: Up to 9 Months
Number of participants with clinically significant changes in electrocardiogram parameters
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 9 Months
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
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Local Institution
Cleveland, Ohio, United States
Local Institution - 9003
Charlottesville, Virginia, United States
Local Institution - 0011
Pilar, Buenos Aires, Argentina
Local Institution - 0010
ABB, Buenos Aires F.D., Argentina
Local Institution - 0014
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0012
Buenos Aires, Argentina
Local Institution - 0085
Bogotá, Bogota D.C., Colombia
Local Institution - 0084
Bogota, Cundinamarca, Colombia
...and 8 more locations
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 9 Months
Number of Participants with clinically significant changes in Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: Up to 9 Months
Incidence of clinically significant changes in clinical laboratory results: Liver Function tests
Time frame: Up to 9 Months
Number of clinically significant changes in physical examinations
Time frame: Up to 9 Months
Number of participants with a recording of concomitant medications
Time frame: Up to 9 Months
Number of participants with a recording of concomitant procedures
Time frame: Up to 9 Months