A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO4917838; Drug: Placebo to RO4917838; Other: Alcohol

• Registration Number: NCT01543529
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-28
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-02-28
• Study First Posted: 2012-03-05
• Primary Completion: 2012-06-04
• Study Completion: 2012-06-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RO4917838 placebo + alcohol	Alcohol	-
RO4917838 + alcohol	Alcohol	-
RO4917838 + non-alcoholic drink	RO4917838	-
RO4917838 + alcohol	RO4917838	-
RO4917838 placebo + alcohol	Placebo to RO4917838	-
RO4917838 placebo + non-alcoholic drink	Placebo to RO4917838	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BIOTRIAL; 🇫🇷 Rennes, France