Healthy Volunteers Clinical Trial
Official title:
Phase 1, Open Label, Randomized, 3-sequence, 3-period, Single Dose Study Assessing the Effect of Food on the Bioavailability of Venglustat Tablet and Comparing the Relative Bioavailability of Venglustat Tablet Chewed Versus Tablet Swallowed Whole
The purpose of this study is to assess the effect of food on the bioavailability of venglustat and to assess the relative bioavailability of venglustat tablet swallowed whole with water versus a tablet chewed and then swallowed without water. Also, to evaluate the safety and tolerability of a single dose tablet of venglustat under fed (swallowed whole) and fasted (swallowed whole or chewed) conditions in healthy adult participants. The maximum duration for participants from screening is up to 63 days.
Total study duration for participants is up to 63 days including screening up to 27 days, 1 day of treatment in period 1 of 7 days, washout of 3 days, 1 day of treatment in period 2 of 7 days, washout of 3 days, 1 day of treatment in period 3 of 7 days, followed by a final observation over 7 days (+/- 2 days). ;
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