Trials / Completed
CompletedNCT03040635
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) in Healthy Japanese Participants
An Investigator/Subject Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of RO7034067 in Healthy Japanese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of Risdiplam in healthy Japanese participants.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Risdiplam | Single oral doses of Risdiplam will be administered on Day 1. |
| DRUG | Placebo | Single oral doses of Risdiplam matching placebo will be administered on Day 1. |
Timeline
- Start date
- 2017-03-22
- Primary completion
- 2017-10-02
- Completion
- 2017-10-02
- First posted
- 2017-02-02
- Last updated
- 2018-10-04
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03040635. Inclusion in this directory is not an endorsement.