drugset / Trial / NCT02104648

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

NCT02104648

Phase 1 Completed 203 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-04
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Moxifloxacin Small molecule 400 mg Oral
Subject RO4602522 Unknown Oral

Indications

No indication recorded.