An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and
pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement therapy.
The dose levels of PRX-112 are 50 units, 100 units, 200 units and 400 units GCD. Subjects
will receive once daily oral administrations of PRX-112 for 5 consecutive days at each dose
level with a 2-day washout period between doses.