A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-06-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ethanol

Criteria

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