Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 169 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01613040
The ClinicalTrials.gov registry entry for NCT01613040 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 169 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 3 interventions - of which Moxifloxacin is the first listed.
NCT01613040 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.