The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers. The data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
PRA International
Groningen, Netherlands
Plasma pharmacokinetics of migalastat
To investigate the effect on the body of migalastat following a single 2 hour IV infusion in healthy subjects.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2.0, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48
Safety and tolerability of migalastat
Adverse events, clinical laboratory test values, vital signs, ECG, physical examinations
Time frame: 48 hours
Plasma pharmacokinetics of migalastat
To assess the dose proportionality of migalastat following a single 2 hour IV infusion
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2.0, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 48
Urinary pharmacokinetics
To estimate the urinary excretion of unchanged migalastat following a single 2 hour IV infusion in healthy subjects
Time frame: Pre dose, between 0-6, 6-12 and 12-24 hours after start of infusion
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