A Single-center, Open-label, Single Dose, Randomized, Two-way Cross-over Study to Investigate the Pharmacokinetics, Safety, and Tolerability of RO4917838 in Healthy Chinese Volunteers

Hoffmann-La Roche0 sites16 target enrollmentSeptember 2011

ConditionsHealthy Volunteer

InterventionsRO4917838

DrugsRO4917838

Overview

Phase: Phase 1
Intervention: RO4917838
Conditions: Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 16
Primary Endpoint: Pharmacokinetics: Area under the concentration-time curve (AUC)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

November 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening
•Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination
•Body mass index (BMI) 19 to 28 kg/m2 inclusive

Exclusion Criteria

•Pregnant or currently lactating females
•History of any clinically relevant disorder
•Any history of depressive episodes or treatment with antidepressants
•History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1
•Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1
•Positive for HIV, hepatitis B or hepatitis C infection
•Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco
•Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing
•Medical history of significant drug allergies