A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers
NCT01543529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2017-05-10
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.
Conditions
- Healthy Volunteer
Interventions
- DRUG
-
RO4917838
Single dose of RO4917838
- DRUG
-
Placebo to RO4917838
Single dose of placebo to RO4917838
- OTHER
-
Alcohol
Standard alcoholic drink
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-02-28
- Primary Completion
- 2012-06-04
- Completion
- 2012-06-04
Countries
- France
Study Locations
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