Conditions: Healthy Volunteers
Keywords: Radiolabelled AME
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Radiolabeled SPD557
Intervention descriptions: intervention 1: A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

Protocol document: