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

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.

Timeline

Start

2009-01

Primary completion

2009-07

Completion

2009-07

Outcome

Met primary endpoint

paper The upper bound of the 1-sided 95% CI was <10 milliseconds at all time points with both doses. PMID 22980315 ↗

paper Multiple dosing with bitopertin 30 mg or 175 mg did not affect QTcF in these healthy male volunteers. PMID 22980315 ↗

Publications

• Hofmann C, Banken L, Hahn M, Swearingen D, Nagel S, Martin-Facklam M. Evaluation of the effects of bitopertin (RG1678) on cardiac repolarization: a thorough corrected QT study in healthy male volunteers. Clin Ther. 2012 Oct;34(10):2061-71. doi: 10.1016/j.clinthera.2012.08.010. Epub 2012 Sep 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Moxifloxacin	Small molecule	400 mg	Oral
Subject	bitopertin	Small molecule	30 mg	Oral
Subject	bitopertin	Small molecule	175 mg	Oral

Indications

No indication recorded.