A Phase 1, Randomized, Double-Blind, Placebo Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride given Intravenously to Healthy Volunteers with an Open-Label, Randomized, Two-Way Crossover Arm
Completed
- Conditions
- Fabry diseaselysosomal storage disease10083624
- Registration Number
- NL-OMON40853
- Lead Sponsor
- Amicus Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
Inclusion Criteria
- healthy male and female subjects
- 18-45 yrs, inclusive
- BMI: 18.5-29.9 kg/m2, inclusive
- non-smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days prior to dosing day or being a blood donor (>500 mL) within 60 days from the start of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Plasma pharmacokinetics<br /><br>2. Safety: adverse events including infusion site reactions, clinically<br /><br>significant changes in safety laboratory tests, vital signs, physical<br /><br>examinations, and ECG</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Plasma pharmacokinetics<br /><br>2. Urinary pharmacokinetics</p><br>