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

NCT01196065 | Completed Phase 1

• 2 other identifiers: BP251802010-020080-20
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

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

  Days 16-21

Secondary Outcomes (2)

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

  up to 14 weeks

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

  up to 7 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: RO5313534; Drug: memantine

Interventions

RO5313534 DRUG

single oral dose

Single Arm

memantine DRUG

multiple doses to steady state

Single Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Rennes, 35042, France

Location

MeSH Terms

Interventions

Memantine

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 8, 2010
• Study Start: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

FR (1)