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An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion of Radio Labeled SPN-810M in Healthy Adult Male Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPN-810M | Experimental | Single dose of 20 mL solution containing 50 mg of SPN-810M and no less than 8.5 MBq (225 µCi) carbon-14 (14C)-SPN-810M, and no more than 11.3 MBq (305 µCi) [14C] SPN-810M. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPN-810M | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary and fecal recoveries (mass balance) of total radioactivity. | C(urine and feces), Ae(urine and feces), CumAe(urine and feces), % Dose(urine and feces), CUM% Dose(urine and feces). | 10 days post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Whole blood and plasma partitioning of total radioactivity. | To determine whole blood and plasma partitioning of total radioactivity | 10 days post dose. |
| Pharmacokinetics (PK) of total radioactivity in plasma. |
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Key Entry:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Collier, MBChB | Quotient Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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PK of total radioactivity in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2).
| 10 days post dose. |
| PK of SPN-810 in plasma. | PK of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2). | 10 days post dose. |
| PK of the major metabolites of SPN-810 in plasma. | PK of the major metabolites of SPN-810 in plasma (Cmax, Tmax, AUC0-t, AUCinf, Kel, and t1/2). | 10 days post dose. |
| Metabolites of SPN-810 in plasma, urine and feces | To characterize and identify the metabolites of SPN-810 in plasma, urine and feces. | 10 days post dose. |
| Safety and tolerability of SPN-810. | To assess the safety and tolerability of SPN-810 by collecting Adverse Events. | 10 days post dose. |