NCT01543529
Completed
Phase 1
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
ConditionsHealthy Volunteer
Overview
- Phase
- Phase 1
- Intervention
- Alcohol
- Conditions
- Healthy Volunteer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
RO4917838 + alcohol
Intervention: Alcohol
RO4917838 + non-alcoholic drink
Intervention: RO4917838
RO4917838 + alcohol
Intervention: RO4917838
RO4917838 placebo + alcohol
Intervention: Placebo to RO4917838
RO4917838 placebo + alcohol
Intervention: Alcohol
RO4917838 placebo + non-alcoholic drink
Intervention: Placebo to RO4917838
Outcomes
Primary Outcomes
Effect of alcohol on pharmacodynamics (Cognitive test battery) of RO4917838
Time Frame: Day 1 of each treatment period
Secondary Outcomes
- 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)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study of the Relative Bioavailability of Single Dose RO4917838 and the Effect of Food in Healthy VolunteersHealthy VolunteerNCT01665976Hoffmann-La Roche16
Completed
Phase 1
A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy VolunteersHealthy VolunteerNCT01708616Hoffmann-La Roche24
Completed
Phase 1
A Phase 1 QT Study in Healthy Male SubjectsClinical Pharmacology, Healthy Volunteer StudyNCT01986894Celgene72
Completed
Phase 1
Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to SmokeTobacco Use DisorderTobacco DependenceSmokingNCT01428310Rock Creek Pharmaceuticals, Inc.109
Completed
Phase 1
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy VolunteersHealthy VolunteerNCT01461967Hoffmann-La Roche49