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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO5313534; Drug: memantine

• Registration Number: NCT01196065
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-08
• Study Completion: 2010-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Healthy males and females, 18 to 45 years of age inclusive
• Body mass index (BMI) 18-30 kg/m2
• Male subjects must agree to use a barrier method of contraception from first dosing until the end of the study
• Female subjects must be either surgically sterile or agree to use two forms of contraception until the end of the study
• Non-smoker for at least 6 months

Exclusion Criteria

• Clinically significant history or detection during medical interview/physical examiation of any disease or condition that is capable of altering the absorption. metabolism or elimination of drugs, or would constitute a risk factor when taking the study drug
• History of drug addiction or alcohol abuse
• Any confirmed significant allergic reaction to any drug, or multiple allergies in the judgement of the investigator
• Positive serology to hepatitis B or hepatitis C or Human Immunodeficiency Viruses (HIV type 1 and 2) at screening
• Pregnant or lactating women
• Participation in an investigational drug or device study within the last 3 months prior to first dose

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	RO5313534	-
Single Arm	memantine	-

Primary Outcome Measures

Name	Time	Method
Effect of multiple-dose memantine on single-dose pharmacokinetics of RO5313534 and of RO5313534 on steady-state pharmacokinetics of memantine	Days 16-21

Secondary Outcome Measures

Name	Time	Method
Effect of multiple-dose memantine on safety and tolerability of single-dose RO5313534	up to 14 weeks
Safety and tolerability of memantine alone and in combination with a single dose of RO5313534	up to 7 weeks