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

NCT01730482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2013-12-18

No results posted yet for this study

Summary

This study is designed to describe the metabolism of AT1001 (migalastat HCl) and the contribution of metabolism and urinary excretion to its overall elimination as part of the continuing assessment of the safety and effectiveness of the drug.

This is a Phase 1, single-site, open-label, single dose study of the absorption, metabolism and excretion of radiolabeled AT1001 in healthy male subjects between 30 and 55 years of age, inclusive. Six subjects will be dosed, with the goal of having at least 4 subjects complete the study through follow-up. All subjects will be screened within 28 days before admission to the Clinical Unit. Subjects will be confined to the clinical unit for 10 days after dosing and will return to the clinic for a follow-up visit 28 days after dosing.

Each subject will receive a single oral dose of AT1001 as an aqueous solution containing 150 mg \[14C\] AT1001 (1 μCi). Blood, duodenal bile, expired air, urine, and feces samples will be collected at specified time points after dosing throughout the period of confinement at the study site. Safety will be assessed throughout the study by monitoring clinical laboratory tests, ECGs, physical examinations, vital signs, and adverse events. The total duration of the study for each subject is approximately 8 weeks.

Conditions

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 & Collaborators

  • Amicus Therapeutics

    lead INDUSTRY

Principal Investigators

  • Medical Monitor, Clinical Research · Amicus Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-09-30
Completion
2011-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01730482 on ClinicalTrials.gov