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NCT01613040 · ClinicalTrials.gov registry record · Phase 1

A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers

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

Completed
Registry status
Phase 1
Development phase
169
Enrollment target

NCT01613040: Completed Phase 1 study, sponsored by Hoffmann-La Roche.

NCT01613040 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 169 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (182% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01613040, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
169 participants
Enrollment target

Study Summary

This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low dose of RO4917838, Arm B: high dose of RO4917838, Arm C: placebo to RO4917838 and moxifloxacin on Day 1, Arm D: placebo to RO4917838 and moxifloxacin on Day 11. The anticipated time on study treatment is 11 days.

Interventions

  • DRUG Moxifloxacin
  • DRUG RO4917838
  • DRUG RO4917838 placebo

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2009-01
Est. Completion 2009-07
Phase Phase 1
Hoffmann-La Roche

909 total trials

What the finished NCT01613040 record still lists

NCT01613040 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (182% higher).

The record links to 0 conditions, and to 3 interventions - of which Moxifloxacin is the first listed.

NCT01613040 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01613040 about?

NCT01613040 is a clinical study titled "A Study of the Effect of RO4917838 on the QTcF Interval in Healthy Volunteers". This multiple-center, multiple-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, parallel group study will investigate the effect of RO4917838 on the QTc interval in healthy volunteers. Healthy volunteers will be randomized to one of 4 treatment arms; Arm A: low ...

What is the current status of trial NCT01613040?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 169 participants. The study started on 2009-01. Estimated completion is 2009-07.

What interventions are being tested in trial NCT01613040?

The interventions under investigation include: Moxifloxacin (DRUG), RO4917838 (DRUG), RO4917838 placebo (DRUG).

Who is sponsoring clinical trial NCT01613040?

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 NCT01613040's enrollment target sits among peer trials

169 326th of 2000 higher than 1,675 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 NCT01613040, the US trial registry maintained by the National Library of Medicine. NCT01613040 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.