This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period. The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
71
Research Site
Melbourne, Victoria, Australia
Research Site
Hong Kong, Hong Kong, China
AUC of BG00012
Time frame: First dose to 24 hours
Cmax of BG00012
Time frame: First dose to 24 hours
Number of Adverse Events, as a measure of safety and tolerability
Time frame: Subjects will be followed for the duration of the study, an expected 20 days
Number of Serious Adverse Events, as a measure of safety and tolerability
Time frame: Subjects will be followed for the duration of the study, an expected 20 days
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