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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSP-5336 tablets and [14C]-DSP-5336 solution | Experimental | Part 1 |
|
| Optional Continued Access | Experimental | Part 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSP-5336 | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of radioactivity in urine as percentage of total radioactive dose of [14C]-DSP-5336 | The percentage of dose excreted in urine | 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 | 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 | 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. | 4 days, max 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 days, max 7 days |
| Cmax for the relative bioavailability of [14C]-DSP-5336 |
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Inclusion Criteria:
Exclusion Criteria:
Male, female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holly Beever | Contact | 774-405-5261 | holly.beever@us.sumitomo-pharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Not yet recruiting | Chapel Hill | North Carolina | 27514 | United States |
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| [14C]-DSP-5336 | Drug | oral solution |
|
Analysis of the maximum concentration (Cmax) of the relative bioavailability of [14C]-DSP-5336 utilizing the ratio of the adjusted geometric means |
| 4 days, max 7 days |
| t(1/2) of [14C]-DSP-5336 | Elimination half-life (t[1/2]) of [14C]-DSP-5336 | 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 | 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 | 30 days |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|