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NCT01368926 · ClinicalTrials.gov registry record · Phase 1

A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

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

Completed
Registry status
Phase 1
Development phase
42
Enrollment target

NCT01368926 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 42 participants.

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The verdict

NCT01368926, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
42 participants
Enrollment target

Study Summary

This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523 or placebo orally daily for 14 days.

Interventions

  • DRUG placebo
  • DRUG RO4917523

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2011-06
Est. Completion 2011-11
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01368926

The ClinicalTrials.gov registry entry for NCT01368926 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 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.

NCT01368926 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01368926 about?

NCT01368926 is a clinical study titled "A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects". This double-blind, randomized, placebo-controlled, 2-Part study will evaluate the pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either RO4917523 or placebo, with a washout pe...

What is the current status of trial NCT01368926?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2011-06. Estimated completion is 2011-11.

What interventions are being tested in trial NCT01368926?

The interventions under investigation include: placebo (DRUG), RO4917523 (DRUG).

Who is sponsoring clinical trial NCT01368926?

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

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.