A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Other: Alcohol; Drug: RO4917838; Drug: Placebo to RO4917838

Study type: Interventional

Funder types: Industry

Identifiers

NCT01543529

BP28180

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 4 patient groups, including a placebo group

RO4917838 + non-alcoholic drink

Active Comparator group

Treatment:

Drug: RO4917838

RO4917838 + alcohol

Experimental group

Treatment:

Drug: RO4917838

Other: Alcohol

RO4917838 placebo + alcohol

Placebo Comparator group

Treatment:

Other: Alcohol

Drug: Placebo to RO4917838

RO4917838 placebo + non-alcoholic drink

Placebo Comparator group

Treatment:

Drug: Placebo to RO4917838