A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

January 7, 2016

Primary Completion Date

August 4, 2016

Study Completion Date

August 4, 2016

Conditions
Spinal Muscular Atrophy
Interventions
DRUG

Itraconazole

Itraconazole will be administered as an oral 200 mg dose twice daily from Day 1 to Day 8 in Part 3.

OTHER

Placebo

In Part 1 of the study matching oral placebo will be administered once on Day 1.

DRUG

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).

Trial Locations (1)

9728 NZ

Pra International Group B.V, Groningen

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02633709 - A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) Given by Mouth in Healthy Volunteers | Biotech Hunter | Biotech Hunter