A Study to Assess the Absorption, Metabolism and Excretion of Migalastat Hydrochloride (AT1001-014)

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Fabry Disease
Interventions
DRUG

[14C] AT1001

150 mg of \[14C\] labelled AT1001 will be administered as a solution (prepared by weighing 150 mg of AT1001 powder and dissolving in 100 mL of water). The entire solution will be swallowed orally. After ingestion of study medication, the dosing bottle will be rinsed with 50 mL of water and this will be ingested by the subject. This rinse procedure should be performed twice. Following the second rinse ingestion, the subjects should be instructed to drink additional water to bring the total volume ingested to 240 mL.

Sponsors
All Listed Sponsors
lead

Amicus Therapeutics

INDUSTRY