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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4917838; Other: Alcohol; Drug: Placebo to RO4917838

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35042
    • Biotrial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Alcohol; Standard alcoholic drink; Drug: Placebo to RO4917838; Single dose of placebo to RO4917838
Placebo Comparator: RO4917838 placebo + non-alcoholic drink	Drug: Placebo to RO4917838; Single dose of placebo to RO4917838

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2012
• Primary Completion (Actual): June 4, 2012
• Study Completion (Actual): June 4, 2012

Study Registration Dates

• First Submitted: February 28, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: BP28180