Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5313534

Drug

single oral dose

Memantine

Drug

multiple doses to steady state

Primary outcomes

  1. Effect of multiple-dose memantine on single-dose pharmacokinetics of RO5313534 and of RO5313534 on steady-state pharmacokinetics of memantine

    Time frame: Days 16-21

Secondary outcomes

  1. Effect of multiple-dose memantine on safety and tolerability of single-dose RO5313534

    Time frame: up to 14 weeks

  2. Safety and tolerability of memantine alone and in combination with a single dose of RO5313534

    Time frame: up to 7 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Study completion
2010
First posted
Sep 8, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.