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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: RO5313534; Drug: memantine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01196065

BP25180

2010-020080-20

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: memantine

Drug: RO5313534