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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01196065
• Other study ID #: BP25180
• Secondary ID: 2010-020080-20
• Status: Completed
• Phase: Phase 1
• First received: September 3, 2010
• Last updated: November 1, 2016
• Start date: September 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO5313534
single oral dose
• memantine
multiple doses to steady state

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of multiple-dose memantine on single-dose pharmacokinetics of RO5313534 and of RO5313534 on steady-state pharmacokinetics of memantine		Days 16-21	No
Secondary	Effect of multiple-dose memantine on safety and tolerability of single-dose RO5313534		up to 14 weeks	No
Secondary	Safety and tolerability of memantine alone and in combination with a single dose of RO5313534		up to 7 weeks	No