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

A Single Center, Open-label, Fixed Sequence, Two-period Study to Investigate the Effect of Memantine on Pharmacokinetics, Safety and Tolerability of RO5313534 After Single Dose Administration in Healthy Volunteers and the Effect of RO5313534 on Safety and Tolerability of Steady State Memantine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01196065

Enrollment

Registered

2010-09-08

Start date

2010-09-30

Completion date

2010-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGRO5313534

single oral dose

DRUGmemantine

multiple doses to steady state

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026