A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

A Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics, Safety and Tolerability of RO4917523 Conducted in 2 Phases: a Single-Dose, Cross-Over Administration to Healthy Japanese Subjects and a Multiple-Dose Administration to Healthy Japanese and Caucasian Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368926

Enrollment

Registered

2011-06-08

Start date

2011-06-30

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 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.

Interventions

DRUGRO4917523

single oral doses

DRUGplacebo

oral doses

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Part 1: Pharmacokinetics: Area under the concentration - time curve (AUC) (single/multiple oral dose in healthy Japanese subjects)	approximately 12 weeks
Part 2: Comparison of pharmacokinetics (area under the concentration - time curve [AUC]) between healthy Caucasian and Japanese subjects after 14 days of daily oral dosing	approximately 9 weeks
Safety: Incidence of adverse events in Japanese an Caucasian subjects	approximately 21 weeks

Countries

United States

Outcome results

None listed

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