Clinical 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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

Primary outcomes:
measure: Effect of multiple-dose memantine on single-dose pharmacokinetics of RO5313534 and of RO5313534 on steady-state pharmacokinetics of memantine
timeFrame: Days 16-21
Secondary outcomes:
measure: Effect of multiple-dose memantine on safety and tolerability of single-dose RO5313534
timeFrame: up to 14 weeks
measure: Safety and tolerability of memantine alone and in combination with a single dose of RO5313534
timeFrame: up to 7 weeks
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: