A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers
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
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2012
CompletedStudy Start
First participant enrolled
February 28, 2012
CompletedFirst Posted
Study publicly available on registry
March 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2012
CompletedMay 10, 2017
May 1, 2017
3 months
February 28, 2012
May 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
Day 1 of each treatment period
Secondary Outcomes (2)
Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838
Days 1, 2, 3, 4, 6, and 8 of each treatment period
Safety: Incidence of adverse events
Approximately 4 months
Study Arms (4)
RO4917838 + non-alcoholic drink
ACTIVE COMPARATORRO4917838 + alcohol
EXPERIMENTALRO4917838 placebo + alcohol
PLACEBO COMPARATORRO4917838 placebo + non-alcoholic drink
PLACEBO COMPARATORInterventions
Single dose of placebo to RO4917838
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BIOTRIAL
Rennes, 35042, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2012
First Posted
March 5, 2012
Study Start
February 28, 2012
Primary Completion
June 4, 2012
Study Completion
June 4, 2012
Last Updated
May 10, 2017
Record last verified: 2017-05