The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
14C-bleximenib will be administered orally.
Non-radiolabeled bleximenib will be administered orally.
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom
RECRUITINGPercentage of Dose Excreted in Urine (feu)
Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
Time frame: Up to Day 28
Percentage of Dose Excreted in Feces (fef)
Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.
Time frame: Up to Day 28
Amount Excreted in Urine (Aeu)
Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.
Time frame: Up to Day 28
Amount Excreted in Feces (Aef)
Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.
Time frame: Up to Day 28
Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
AUC0-t in whole blood and plasma will be reported.
Time frame: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)
Maximum Observed Concentration (Cmax)
Maximum observed concentration in whole blood and plasma will be determined.
Time frame: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the study treatment. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.
Time frame: Up to 58 days
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