33
Participants
Start Date
January 7, 2016
Primary Completion Date
August 4, 2016
Study Completion Date
August 4, 2016
Itraconazole
Itraconazole will be administered as an oral 200 mg dose twice daily from Day 1 to Day 8 in Part 3.
Placebo
In Part 1 of the study matching oral placebo will be administered once on Day 1.
Risdiplam
Single ascending oral doses of Risdiplam will be administered on Day 1 of Part 1. In Part 2 a single dose of Risdiplam will be once administered under fasted and once under fed conditions. In Part 3 a single dose of Risdiplam will be once administered alone (Period 1) and once concomitantly to itraconazole (Period 2).
Pra International Group B.V, Groningen
Hoffmann-La Roche
INDUSTRY