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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014