The purpose of this study is to evaluate the absorption, metabolism, and excretion of DSP-5336 following a single oral administration of the study drug in patients with hematologic malignancies whose disease has progressed after available standard therapies.
Male or female, of any race, ≥ 18 years of age. Female patients must be surgically sterile or postmenopausal. Male patients must be permanently sterile or agree to use contraception.
Have an advanced hematological malignancy that is relapsed, refractory, or has progressed following receipt of standard and available treatments.
Any prior pre-treatment toxicities resolved to ≤Grade 1 prior to enrolment, with exception of ≤Grade 2 alopecia or neuropathy.
Adequate kidney and liver function
Histologic diagnosis of acute promyelocytic leukemia.
Abnormal ECG that is clinically significant, such as QTcF > 480 msec. QT interval correction can be performed in the case of bundle branch block.
History of torsades de pointes.
Left ventricular ejection fraction ≤ 45%, as determined by echocardiogram.
Sequential
DSP-5336
Drugtablet
[14C]-DSP-5336
Drugoral solution
Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336
The percentage of dose excreted in urine
Total recovery of radioactivity in fecal waste as percentage of total radioactive dose of [14C]-DSP-5336
The percentage of dose excreted in fecal waste
Total recovery of radioactivity in excreta balance as percentage of total radioactive dose of [14C]-DSP-5336
The percentage of dose excreted in combined urine and fecal waste
Relative abundance (mean value) of [14C]-DSP-5336
Plasma samples will be analyzed for \[14C\]-DSP-5336 and its metabolites.
Area under the plasma concentration time profile from time zero to time of the last quantifiable concentration (AUClast) of [14C]-DSP-5336
The determination of AUClast using the linear/log trapezoidal rule
Cmax for the relative bioavailability of [14C]-DSP-5336
Analysis of the maximum concentration (Cmax) of the relative bioavailability of \[14C\]-DSP-5336 utilizing the ratio of the adjusted geometric means
t(1/2) of [14C]-DSP-5336
Elimination half-life (t\[1/2\]) of \[14C\]-DSP-5336
Ratio of plasma to whole blood total radioactivity
The fraction of \[14C\]-DSP-5336 radioactivity associated with whole blood and plasma and with red blood cells and other cellular components of whole blood was determined by using the concentration of \[14C\]-DSP-5336 radioactivity in whole blood and plasma
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