CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 6 enrolled
Drug / intervention
Radiolabeled SPD602 (FBS0701, SSP-004184)drug
Likely dose
Radiolabeled SPD602 (FBS0701, SSP-004184) 3gfrom 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.

Search/NCT01824446
NCT01824446Phase 1Completed

A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]SSP-004184 Following a Single Oral Dose in Healthy Male Subjects

Shire·interventional·Posted Apr 4, 2013·Updated Jun 24, 2021

In Brief

A Phase 1 clinical trial evaluating Radiolabeled SPD602 (FBS0701, SSP-004184) for Healthy. Completed, enrolled 6 participants across 1 site.

Detailed Summary

To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 4, 2013
Enrollment StartMay 1, 2013
Primary CompletionMay 29, 2013
TodayJul 2, 2026
Enrollment to primary: 28 daysPosted 13.2 years ago

Interventions

Radiolabeled SPD602 (FBS0701, SSP-004184)drug

A single oral dose of 3g of radio-labelled SSP-004184 on Day 1