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| Name | Class |
|---|---|
| Covance | INDUSTRY |
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This is a Phase 1, open-label, nonrandomized, single-dose mass balance and metabolite identification study in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-KBP-5074 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KBP-5074 | Drug | a single oral dose of [14C]-KBP-5074 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance of KBP-5074 | Percentage of total radioactivity recovered in urine and feces following a single dose [14C]-KBP-5074 | up to 240 hours postdose |
| Pharmacokinetic Parameter: Area under the concentration-time curve from time 0 to infinity (AUC0-∞) | Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma | up to 216 hours postdose |
| Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) | Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma | up to 216 hours postdose |
| Pharmacokinetic Parameter: Time of the maximum observed concentration (Cmax) | Time of the maximum observed concentration (Cmax) - Plasma | up to 216 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite radioprofiling and identification in plasma, urine and feces | Select plasma, urine, and fecal samples will be processed and subject to metabolite analysis by LC/MS & LC/MS/MS using high-resolution mass spectrometry. | up to 240 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James McCabe | KBP Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000716354 | KBP-5074 |
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