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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01543529

Enrollment

Registered

2012-03-05

Start date

2012-02-28

Completion date

2012-06-04

Last updated

2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGRO4917838

Single dose of RO4917838

DRUGPlacebo to RO4917838

Single dose of placebo to RO4917838

OTHERAlcohol

Standard alcoholic drink

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838	Day 1 of each treatment period

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026