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A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]RIST4721 | Experimental | [14C]RIST4721 oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]RIST4271 | Drug | [14C]RIST4271 oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance recovery of total radioactivity in all excreta: CumAe | Day 1 to Day 17 | |
| Mass balance recovery of total radioactivity in all excreta: Cum%Ae | Day 1 to Day 17 | |
| Determination of routes and rates of elimination of [14C]RIST4721 by Ae | Day 1 to Day 17 | |
| Determination of routes and rates of elimination of [14C]RIST4721 by %Ae | Day 1 to Day 17 | |
| Determination of routes and rates of elimination of [14C]RIST4721 by CumAe | Day 1 to Day 17 | |
| Determination of routes and rates of elimination of [14C]RIST4721 by Cum%Ae by interval | Day 1 to Day 17 | |
| Collection of plasma, urine and fecal samples for metabolite profiling | Day 1 to Day 17 | |
| Collection of plasma, urine and fecal samples for structural identification | Day 1 to Day 17 | |
| Collection of plasma, urine and fecal samples for quantification analysis | Day 1 to Day 17 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Ltd | Nottingham | United Kingdom |
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