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NCT03040635 · ClinicalTrials.gov registry record · Phase 1

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) in Healthy Japanese Participants

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT03040635: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT03040635 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03040635, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Risdiplam

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2017-03-22
Est. Completion 2017-10-02
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT03040635 record still lists

NCT03040635 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03040635 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03040635 about?

NCT03040635 is a clinical study titled "A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Risdiplam (RO7034067) in Healthy Japanese Participants". 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.

What is the current status of trial NCT03040635?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-03-22. Estimated completion is 2017-10-02.

What interventions are being tested in trial NCT03040635?

The interventions under investigation include: Placebo (DRUG), Risdiplam (DRUG).

Who is sponsoring clinical trial NCT03040635?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03040635's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03040635, the US trial registry maintained by the National Library of Medicine. NCT03040635 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.