Status:
COMPLETED
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01196065
Start Date
September 1 2010
End Date
November 1 2010
Last Update
November 2 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rennes, France, 35042