MedDataX Logo

A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

NCT ID: NCT01433575

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Group Type EXPERIMENTAL

RO4917838

Intervention Type DRUG

10 mg single oral dose

B

Group Type EXPERIMENTAL

RO4917838

Intervention Type DRUG

20 mg single oral dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RO4917838

10 mg single oral dose

Intervention Type DRUG

RO4917838

20 mg single oral dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BP25274

Identifier Type: -

Identifier Source: org_study_id