MedDataX Logo

A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

NCT ID: NCT01368926

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

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 double-blind, randomized, placebo-controlled, 2-Part study will evaluate the pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian volunteers. In Part 1, healthy Japanese volunteers will be randomized to receive 2 oral doses of either RO4917523 or placebo, with a washout period of 21 days between dosing. In Part 2, healthy Japanese and Caucasian volunteers will be randomized in cohorts to receive either RO4917523 or placebo orally daily for 14 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

DOUBLE

Participants Investigators

Study Groups

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

Part 1

Group Type EXPERIMENTAL

RO4917523

Intervention Type DRUG

single oral doses

placebo

Intervention Type DRUG

oral doses

Part 2

Group Type EXPERIMENTAL

RO4917523

Intervention Type DRUG

multiple oral doses

placebo

Intervention Type DRUG

oral doses

Interventions

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

RO4917523

single oral doses

Intervention Type DRUG

RO4917523

multiple oral doses

Intervention Type DRUG

placebo

oral doses

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 Japanese (Part 1 + 2) or Caucasian (Part 2) adults, 18- 50 years of age
* Japanese subjects must have Japanese parents and grandparents who were born in Japan
* Caucasian subjects must have 4 Caucasian grandparents
* Body mass index (BMI) 18.5 to 26 kg/m2, and a body weight of at least 45 kg
* Non-smoker for at least 90 days prior to dosing Day 1

Exclusion Criteria

* Participation in a clinical trial with an investigational drug within 90 days prior to dosing Day 1. (Volunteers having participated in Part 1 will not be allowed to participate in Part 2 and vice versa)
* History or evidence of any clinically significant disease or disorder
* Pregnant or lactating women
* Positive for hepatitis B, hepatitis C or HIV
* Positive drug screen test, positive cotinine test and/or positive alcohol test
* Any confirmed significant allergic reactions to any drug, or multiple allergies in the judgement of the investigator
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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.

New York, New York, United States

Site Status

Countries

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

United States

Other Identifiers

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

BP25713

Identifier Type: -

Identifier Source: org_study_id