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

Phase 1 Completed 6 enrolled Shire

NaSingle-groupOpen-labelBasic science

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.

Timeline

Start: 2013-03-07
Primary completion: 2013-04-12
Completion: 2013-04-12

Publications

Results Flach S, Croft M, Ding J, Budhram R, Pankratz T, Pennick M, Scarfe G, Troy S, Getsy J. Pharmacokinetics, absorption, and excretion of radiolabeled revexepride: a Phase I clinical trial using a microtracer and accelerator mass spectrometry-based approach. Drug Des Devel Ther. 2016 Sep 27;10:3125-3132. doi: 10.2147/DDDT.S107843. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	revexepride	Unknown	2 mg	Oral

Indications

No indication recorded.