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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-07

Study Completion Date

2013-04-12

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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Radiolabeled SPD557

Group Type EXPERIMENTAL

Radiolabeled SPD557

Intervention Type DRUG

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

Interventions

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Radiolabeled SPD557

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

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes