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NCT02165332 · ClinicalTrials.gov registry record · Phase 1
A Two-part, Single-dose, Randomized Study to Evaluate the Safety of Supra-therapeutic Doses of RO7033877 and to Investigate the Effect of RO7033877 on the QTc Interval
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
NCT02165332 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 64 participants.
The verdict
NCT02165332, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
Study Summary
This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind, placebo-controlled study to determine the safety tolerability and pharmacokinetics of a supratherapeutic dose to be used in Part 2. Participants will be randomized in up to 8 cohorts to receive a single dose of either RO7033877 or placebo. Part 2 will be a single dose, randomized, double-blind, double dummy, placebo-controlled, positive control, 4-way crossover study. Part 2 will evaluate whether a single therapeutic or supratherapeutic dose of RO7033877 has a threshold pharmacologic effect on cardiac repolarization, as detected by changes in the QT/QTc interval measured by electrocardiogram (ECG). Pharmacokinetic parameters will be assessed for Parts 1 and 2, continuous ECG recordings will be evaluated in Part 2.
Interventions
- DRUG Part 1: SAD RO7033877
- DRUG Part 1: SAD placebo
- DRUG Part 2: Treatment A, RO7033877
- DRUG Part 2: Treatment B, RO7033877
- DRUG Part 2: Treatment C, moxifloxacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02165332
The ClinicalTrials.gov registry entry for NCT02165332 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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 5 interventions - of which Part 1: SAD RO7033877 is the first listed.
NCT02165332 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02165332 about?
NCT02165332 is a clinical study titled "A Two-part, Single-dose, Randomized Study to Evaluate the Safety of Supra-therapeutic Doses of RO7033877 and to Investigate the Effect of RO7033877 on the QTc Interval". This is a two-part study to evaluate the safety and tolerability of supratherapeutic doses of RO7033877 (Part 1) and to investigate the effect of RO7033877 on the QTc interval in healthy volunteers (Part 2). Part 1 is a single ascending dose, randomized, observer-blind, placebo-controlled study to d...
What is the current status of trial NCT02165332?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2014-07. Estimated completion is 2014-11.
What interventions are being tested in trial NCT02165332?
The interventions under investigation include: Part 1: SAD RO7033877 (DRUG), Part 1: SAD placebo (DRUG), Part 2: Treatment A, RO7033877 (DRUG), Part 2: Treatment B, RO7033877 (DRUG), Part 2: Treatment C, moxifloxacin (DRUG).
Who is sponsoring clinical trial NCT02165332?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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