A phase 1 study to investigate the absorption, metabolism and excretion of [14C] AT1001 (migalastat hydrochloride) following a single oral administration in healthy volunteers.

Completed

• Conditions: Metabolic disease; 10021605

• Registration Number: NL-OMON35820
• Lead Sponsor: Amicus Therapeutics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Healthy male subjects, 30 - 55 years, BMI of *18.0 to *30.0, no smoking.

Exclusion Criteria

Suffering from: hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Criteria for evaluation<br /><br>Radiokinetics : total radioactivity in plasma, urine and faeces, cumulative<br /><br>excretion (also based on the area under the excretion rate versus time curves<br /><br>in urine and faeces, metabolite elucidation and identification<br /><br><br /><br>Pharmacokinetics :<br /><br>plasma, urine and faeces AT1001 concentrations, pharmacokinetic parameters<br /><br><br /><br>Safety : adverse events, vital signs, ECG-parameters, laboratory parameters,<br /><br>physical examination</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>