drugset / Trial / NCT01433575

A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

NCT01433575

Phase 1 Completed 16 enrolled Hoffmann-La Roche
RandomizedCrossoverOpen-label

Summary

This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.

Timeline

Start
2011-09
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject bitopertin Small molecule 10 mg Oral
Subject bitopertin Small molecule 20 mg Oral

Indications

No indication recorded.