A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01543529
First received: February 28, 2012
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

This single-center, randomized, double-blind, four-period crossover study will investigate the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and alcohol, and placebo to RO4917838 and non-alcoholic drink.


Condition Intervention Phase
Healthy Volunteer
Drug: RO4917838
Drug: Placebo to RO4917838
Other: Alcohol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Single Center, Randomized, Double-blind, Single-dose, Four Period, Crossover Study to Investigate Pharmacodynamics and Pharmacokinetics of RO4917838 Alone or With Concomitant Administration of Alcohol in Healthy Volunteers

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838 [ Time Frame: Day 1 of each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838 [ Time Frame: Days 1, 2, 3, 4, 6, and 8 of each treatment period ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: Approximately 4 months ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RO4917838 + non-alcoholic drink Drug: RO4917838
Single dose of RO4917838
Experimental: RO4917838 + alcohol Drug: RO4917838
Single dose of RO4917838
Other: Alcohol
Standard alcoholic drink
Placebo Comparator: RO4917838 placebo + alcohol Drug: Placebo to RO4917838
Single dose of placebo to RO4917838
Other: Alcohol
Standard alcoholic drink
Placebo Comparator: RO4917838 placebo + non-alcoholic drink Drug: Placebo to RO4917838
Single dose of placebo to RO4917838

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult healthy volunteers, 18 to 45 years, inclusive
  • Body Mass Index (BMI) 18 to 30 kg/m2, inclusive
  • Non-smoker or smoker of fewer than 10 cigarettes per day
  • Females, who are not menopausal must agree to use two adequate methods of contraception

Exclusion Criteria:

  • Any current medical condition or disease that would render the volunteer unsuitable for the study, or would place the volunteer at undue risk
  • History of alcoholism
  • History of drug abuse and/or addiction within one year of study start
  • History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543529

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: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01543529     History of Changes
Other Study ID Numbers: BP28180
Study First Received: February 28, 2012
Last Updated: November 1, 2012
Health Authority: France: National Consultative Ethics Committee for Health and Life Sciences

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014