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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
tablet
oral solution
University of North Carolina
Chapel Hill, North Carolina, United States
NOT_YET_RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGTotal recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336
The percentage of dose excreted in urine
Time frame: Day 1 to 4, max 7 days if less than 90% is collected by Day 4
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
Time frame: Day 1 to 4, max 7 days if less than 90% is collected by Day 4
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
Time frame: Day 1 to 4, max 7 days if less than 90% is collected by Day 4
Relative abundance (mean value) of [14C]-DSP-5336
Plasma samples will be analyzed for \[14C\]-DSP-5336 and its metabolites.
Time frame: 4 days, max 7 days
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
Time frame: 4 days, max 7 days
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
Time frame: 4 days, max 7 days
t(1/2) of [14C]-DSP-5336
Elimination half-life (t\[1/2\]) of \[14C\]-DSP-5336
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4 days, max 7 days
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
Time frame: 4 days, max 7 days
Number of participants with adverse events and serious adverse events
Safety of DSP-5336 by reporting of AEs and SAEs
Time frame: 30 days