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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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01196065
First received: September 3, 2010
Last updated: July 19, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Volunteer
 Drug: RO5313534
Drug: memantine
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of multiple-dose memantine on single-dose pharmacokinetics of RO5313534 and of RO5313534 on steady-state pharmacokinetics of memantine [ Time Frame: Days 16-21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of multiple-dose memantine on safety and tolerability of single-dose RO5313534 [ Time Frame: up to 14 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability of memantine alone and in combination with a single dose of RO5313534 [ Time Frame: up to 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: September 2010
Study Completion Date: March 2011
Arms Assigned Interventions
Experimental: Single Arm Drug: RO5313534
single oral dose
Drug: memantine
multiple doses to steady state

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01196065

Locations
France
Rennes, France, 35000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01196065     History of Changes
Other Study ID Numbers: BP25180, 2010-020080-20
Study First Received: September 3, 2010
Last Updated: July 19, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Memantine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
 Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013