Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M

Study Overview
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Brief Summary
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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

Official Title
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An Open-Label, Single-Dose, Mass-Balance Study to Assess the Absorption, Metabolism, and Excretion (AME) of [14C] Labeled SPN-810M in Healthy Adult Male Volunteers

Conditions
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Impulsive Aggression Comorbid With ADHD

Intervention / Treatment
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* Drug: SPN-810M


Participation Criteria
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Eligibility Criteria
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Key Entry: Healthy males. Aged 30 to 55 years. Considered medically healthy by the Investigator via assessment of physical examination, medical history, clinical laboratory tests, urinalysis, vital signs, and electrocardiogram. Able to voluntarily provide written informed consent to participate in the study.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPN-810M<br>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. | Drug: SPN-810M<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impulsive Aggression, ADHD