Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function

Completed · Phase 1

Conditions studied: Fabry Disease

In brief

This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects with normal renal function and to subjects with mild, moderate, and severe renal impairment.

Key facts

Study ID

NCT01730469

Run by

Amicus Therapeutics

People needed

32

Starts

2011-08-01

Expected to finish

2012-04-01

Last updated by the study team

2017-08-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• All subjects:
• history of hypersensitivity or allergies to any drug, unless approved by the Investigator and reviewed by Sponsor/Medical Monitor
• participation in a study with receipt of an investigational drug < 5 half-lives or 30 days (whichever is longer) before Check-in
• use of alcohol, grapefruit, or caffeine-containing foods or beverages < 72 hours before Check-in, unless approved by the Investigator and reviewed by the Sponsor/Medical Monitor
• poor peripheral venous access
• whole blood donation < 56 days before dosing or plasma donation < 14 days before dosing
• receipt of blood products < 2 months before Check-in
• history or presence of any clinically significant abnormal ECG
• history of alcoholism or drug addiction < 1 year before Check-in
• positive test for HIV antibody, HBsAg or anti-HCV
• pregnant or breastfeeding
• Healthy subjects with normal renal function:
• use of any tobacco- or nicotine-containing products < 6 months before Check-in
• clinically significant (history of or active) cardiac, hepatic, pulmonary, endocrine, neurological, infectious, gastrointestinal, hematologic, oncologic, or psychiatric disease putting the subject at increased risk or could interfere with study objectives
• screening laboratory values outside normal range and deemed clinically significant by the Investigator
• use of a prescription drug < 14 days of dosing or a non-prescription drug < 7 days before dosing or need of concomitant medication during the study
• Subjects with mild, moderate, or severe renal impairment:
• unstable disease (concurrent medical conditions that have changed significantly < 90 days)
• changes in concomitant prescription medications < 30 days before dosing or expected changes during study
• use of new non-prescription medication < 30 days before dosing
• renal transplant
• acute or chronic non-renal condition limiting the subject's ability to complete and/or participate in the study

Where it is running

• GSK Investigational Site — Costa Mesa, California, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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