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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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 24 participants.

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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

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT03040635

The ClinicalTrials.gov registry entry for NCT03040635 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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

NCT03040635 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.