drugset / Trial / NCT01495104

A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers

NCT01495104

Phase 1 Completed 18 enrolled Hoffmann-La Roche
RandomizedSingle-groupOpen-label

Summary

This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.

Timeline

Start
2011-10
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproate Small molecule
Subject bitopertin Small molecule

Indications

No indication recorded.