A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers

NCT01543529 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-05-10

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

RO4917838

Single dose of RO4917838

DRUG

Placebo to RO4917838

Single dose of placebo to RO4917838

OTHER

Alcohol

Standard alcoholic drink

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-28
Primary Completion
2012-06-04
Completion
2012-06-04

Countries

  • France

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01543529 on ClinicalTrials.gov