A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01433575

Enrollment

Registered

2011-09-14

Start date

2011-09-30

Completion date

2011-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGRO4917838

10 mg single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: Area under the concentration-time curve (AUC)	12 days
Pharmacokinetics: Peak plasma concentrations (Cmax)	12 days

Secondary

Measure	Time frame
Safety: Incidence of adverse events	approximately 4 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026