AME (Absorption, Metabolism, and Excretion) of Radiolabeled SSP-004184

Study Overview
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Brief Summary
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To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.

Official Title
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A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]SSP-004184 Following a Single Oral Dose in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Radiolabeled SPD602 (FBS0701, SSP-004184)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male subjects aged between 18 and 65 years inclusive Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiolabeled SPD602<br> | Drug: Radiolabeled SPD602 (FBS0701, SSP-004184)<br>* A single oral dose of 3g of radio-labelled SSP-004184 on Day 1<br>* Other names: SPD602;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184 | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184 | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184 | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Plasma Half-Life (T1/2) of Radiolabelled SSP-004184 | The time it takes for the blood plasma concentration of a substance to halve. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Total Body Clearance (CL/F) of Radio-Labelled SSP-004184 | The rate at which a drug is removed from the body. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Volume of Distribution (Vz/F) of Radiolabelled SSP-004184 | The distribution of a medication between plasma and the rest of the body. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. | 
| Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184 |  | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |