The purpose of this study was to evaluate the safety and tolerability, and the pharmacokinetic and biologic activity of INCB059872 in participants with sickle cell disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
INCB059872 tablets
Acevedo Clinical Research Associates
Miami, Florida, United States
Advanced Pharma
Miami, Florida, United States
Vita Health and Medical Center
Tamarac, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Safety and tolerability of INCB059872 assessed by monitoring frequency, duration, and severity of adverse events
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent.
Time frame: Screening through 35 days after end of treatment, up to approximately 3 months per participant.
Change in fetal hemoglobin (HbF) from baseline
Pharmacodynamic activity assessed by measuring changes of HbF from baseline and their correlation to INCB059872 treatment. The HbF (F cells) in human whole blood will be characterized using flow cytometry.
Time frame: Baseline through 2 weeks after end of treatment, up to approximately 2.5 months per participant.
Cmax of INCB059872
Defined as maximum observed plasma concentration.
Time frame: Baseline to Day 28.
AUC0-t of INCB059872
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.
Time frame: Baseline to Day 28.
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Boston University
Boston, Massachusetts, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Blood Centers of Wisconsin
Milwaukee, Wisconsin, United States