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| Name | Class |
|---|---|
| Quotient Sciences | INDUSTRY |
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The purpose of the study is to measure how the radiolabelled test medicine [14C]-Uproleselan (GMI-1271) is taken up, broken down and removed from the body when given intravenously (into a vein) in a group of 6 males. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the drug is in the body. Blood urine and fecal samples will be collected at specific times throughout the study to measure amounts of the test medicine in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single IV administration of [14C]-Uproleselan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uproleselan | Drug | [14C]-Uproleselan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance Recovery | Urine and feces will be collected at different time points and the radioactivity will be measured. The recovery will be expressed as percentage of radioactivity administered | up to 8 days |
| Tmax | The time from dosing at which Cmax was apparent | up to 8 days |
| Cmax | maximum observed concentration | up to 8 days |
| AUC(0-last) | area under the curve from 0 time to last measurable concentration | up to 8 days |
| AUC(0-inf) | area under the curve from 0 time extrapolated to infinity | up to 8 days |
| AUC%extrap | percentage of AUC(0-inf) extrapolated beyond last measured time point | up to 8 days |
| lambda-z | the apparent elimination rate constant | up to 8 days |
| T1/2 | the apparent elimination half-life | up to 8 days |
| CI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nand Singh, MD,DPM,MFPM | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Limited | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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clearance, the apparent volume cleared of parent drug per unit time after intravenous administration |
| up to 8 days |
| Vx | the apparent volume of distribution after intravenous administration | up to 8 days |
| MRT | mean residence time | up to 8 days |
| Ae(urine) | the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose | up to 8 days |
| %Ae(urine) | the amount of Uproleselan excreted in the urine expressed as a percentage of the administered dose | up to 8 days |
| CLr | renal clearance: the apparent volume of plasma cleared of Uproleselan per unit time via renal elimination, calculated as: CLr = Ae (urine) / AUC | up to 8 days |
| ID | Term |
|---|---|
| C000654285 | uproleselan |
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