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NCT Number: NCT01543529

A Pharmacodynamic and Pharmacokinetic Study of RO4917838 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BIOTRIAL

Rennes, 35042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO4917838

Drug

Single dose of RO4917838

Placebo to RO4917838

Drug

Single dose of placebo to RO4917838

Alcohol

Other

Standard alcoholic drink

Primary outcomes

  1. Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838

    Time frame: Day 1 of each treatment period

Secondary outcomes

  1. Effect of alcohol on pharmacokinetics (Area under the concentration time curve) of RO4917838

    Time frame: Days 1, 2, 3, 4, 6, and 8 of each treatment period

  2. Safety: Incidence of adverse events

    Time frame: Approximately 4 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 5, 2012
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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