drugset / Trial / NCT01196065

A Study of the Effect of Memantine on Pharmacokinetics, Safety and Tolerability of Single Dose RO5313534 in Healthy Volunteers, and the Effect of RO5313534 on Safety and Tolerability of Steady State Memantine

NCT01196065

Phase 1 Completed 16 enrolled Hoffmann-La Roche
Non-randomizedSingle-groupOpen-label

Summary

This open-label, fixed sequence, two-period study will assess the effect of memantine on the pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.

Timeline

Start
2010-09
Primary completion
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Memantine Unknown Oral
Subject RO5313534 Unknown Oral

Indications

No indication recorded.