At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
Radiolabeled SPD557drug
Likely dose
Radiolabeled SPD557 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1 Study to Investigate the Absorption, Metabolism and Excretion of [14C]SPD557 Following a Single Oral Dose in Healthy Male Subjects
In Brief
A Phase 1 clinical trial evaluating Radiolabeled SPD557 for Healthy Volunteers. Completed, enrolled 6 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartMar 2013
Primary CompletionApr 2013
TodayJul 2026
First PostedFeb 8, 2013
Enrollment StartMar 7, 2013
Primary CompletionApr 12, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.4 years ago
Interventions
Radiolabeled SPD557drug
A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1