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

Shire6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Radiolabeled SPD557DRUG

A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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.