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NCT02104648 · ClinicalTrials.gov registry record · Phase 1
A 2-Part Study to Evaluate the Safety of Supra-Therapeutic Doses of RO4602522 and to Investigate the Effect of RO4602522 on the QTc Interval
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 203
- Enrollment target
NCT02104648 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 203 participants.
The verdict
NCT02104648, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 203 participants
- Enrollment target
Study Summary
This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized, double-blind, placebo-controlled study. Participants will be randomized to receive daily, oral doses of either RO4602522 or placebo for ten days. Part B of the study will be a multiple-dose, randomized, double-blind, double-dummy, placebo controlled, positive-control, parallel group study. Participants will be randomized to receive either multiple or single doses of RO4602522 or to receive single doses of moxifloxacin for 11 days. Pharmacokinetic parameters will be assessed for Parts A and B; and continuous ECG recordings will be made during Part B.
Interventions
- DRUG RO4602522
- DRUG moxifloxacin
- OTHER Placebo RO4602522
- OTHER moxifloxacin placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 203 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02104648
The ClinicalTrials.gov registry entry for NCT02104648 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 203 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 4 interventions - of which RO4602522 is the first listed.
NCT02104648 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02104648 about?
NCT02104648 is a clinical study titled "A 2-Part Study to Evaluate the Safety of Supra-Therapeutic Doses of RO4602522 and to Investigate the Effect of RO4602522 on the QTc Interval". This is a 2 part study to evaluate the safety and tolerability of supra-therapeutic doses of RO4602522 (Part A); and to investigate the effect of RO4602522 on the QTcF interval in healthy volunteers (Part B). Part A of the study will be a multiple-dose, randomized, double-blind, placebo-controlled s...
What is the current status of trial NCT02104648?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 203 participants. The study started on 2014-04. Estimated completion is 2014-08.
What interventions are being tested in trial NCT02104648?
The interventions under investigation include: RO4602522 (DRUG), moxifloxacin (DRUG), Placebo RO4602522 (OTHER), moxifloxacin placebo (OTHER).
Who is sponsoring clinical trial NCT02104648?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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