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This is an open-label, single-dose study in healthy male subjects to investigate the absorption, metabolism, and excretion (AME) of KW-6356.
Subjects will be screened to assess their eligibility to enter the study within approximately 4 weeks prior to dose administration. Subjects will be confined to the Clinical Research Unit (CRU) for their entire participation in this study. Eight subjects will be enrolled to allow 6 subjects to complete the study. Each subject will report to the CRU and be confined from Day -1 (the day before dosing) through at least Day 8 (168 hours postdose). A single dose of study drug will be administered on Day 1 (0 hour). On Day 8, subjects can be asked to remain as a resident within the CRU for an additional period to allow for ongoing 24-hour urine, fecal, and blood sample collections. These collections can continue up to a maximum of 336 hours postdose (Day 15). Subjects can be discharged prior to Day 15 if the following individual subject discharge criteria have been satisfied: ≥ 90% of the 14C dose recovered in combined urine and feces, and ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 3 consecutive 24-hour periods in which a fecal sample is provided.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KW-6356 | Experimental | Single oral dose of carbon-14-KW-6356. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-6356 | Drug | Single oral dose of KW-6356 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| tmax | Time of maximum observed concentration (KW-6356 in plasma and total radioactivity in plasma and blood). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| AUC0-t | Area under the drug concentration-time curve from time zero to the last quantifiable concentration (KW-6356 in plasma and total radioactivity in plasma and blood). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| %AUCextra | Percentage of estimated part for the calculation of AUC0-∞ (KW-6356 in plasma and total radioactivity in plasma and blood). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| t1/2 | Elimination half-life (KW-6356 in plasma and total radioactivity in plasma and blood). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| kel | Elimination rate constant (KW-6356 in plasma and total radioactivity in plasma and blood). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| Vz/F | Apparent volume of distribution during terminal phase (KW-6356 in plasma). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of subjects experiencing an adverse event related to treatment. | From screening through study completion, an average of 6 weeks. |
| Severe adverse events. | Number of subjects experiencing a severe adverse event related to treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| CL/F | Apparent oral clearance (KW-6356 in plasma). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| MRT | Mean residence time (KW-6356 in plasma). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| Whole blood/plasma concentration ratio (total radioactivity in blood and plasma). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| Aeurine | Cumulative amount excreted in urine (total radioactivity in urine). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| feurine | Fraction of the dose administered excreted in urine (total radioactivity in urine). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| Aefeces | Cumulative amount excreted in feces (total radioactivity in feces). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| fefeces | Fraction of the dose administered excreted in feces (total radioactivity in feces). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| Aetotal | Total amount excreted (total radioactivity in urine and feces). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| fetotal | Fraction of the dose administered excreted in urine and feces (total radioactivity in urine and feces). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| Metabolic profiling and identification (plasma, urine, and feces). | Pre-dose up to 168 hours post dose, up to 336 hours post dose. |
| From screening through study completion, an average of 6 weeks. |
| Serum chemistry, hematology, and urinalysis. | Number of subjects with abnormal laboratory values that are related to treatment. | From screening through study completion, an average of 6 weeks. |
| Vital signs | Number of subjects with abnormal vital signs that are related to treatment. | From screening through study completion, an average of 6 weeks. |
| 12-lead ECG. | Number of subjects with abnormal ECG that are related to treatment. | From screening through study completion, an average of 6 weeks. |
| Physical examination. | Number of subjects with abnormal physical exam findings that are related to treatment. | From screening through study completion, an average of 6 weeks. |