Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers

Study Overview
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Brief Summary
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Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Official Title
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A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 Following a Single Oral Dose in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Radiolabeled SPD557


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Males ages 18 to 50 years Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2 Subject is willing to comply with any applicable contraceptive and sperm donation requirements Key Exclusion criteria: Have participated in a [14C]-study within the last 6 months. Exposure to clinically significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring). Male subjects who consume more than 21 units of alcohol per week or 3 units per day. Subjects who report typically having more than 2 bowel movements per day, less than 3 bowel movements per week or those whose bowel habits have changed significantly within 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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 SPD557<br> | Drug: Radiolabeled SPD557<br>* A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1<br>|

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-002358 | Area under the plasma concentration versus time curve from time 0 to infinity. 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. | Over 240 hours post-dose | 
| Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358 | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered. | Over 240 hours post-dose | 
| Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Plasma Half-Life (T1/2) of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 
| Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358 |  | Over 240 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radiolabelled, AME