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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RO4917523; Drug: RO4917523; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1	Drug: RO4917523; single oral doses; Drug: RO4917523; multiple oral doses; Drug: placebo; oral doses
Experimental: Part 2	Drug: RO4917523; single oral doses; Drug: RO4917523; multiple oral doses; Drug: placebo; oral doses

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 27, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: BP25713