A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RO4917523; Drug: placebo

• Registration Number: NCT01368926
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-27
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1	RO4917523	-
Part 1	placebo	-
Part 2	placebo	-
Part 2	RO4917523	-

Primary Outcome Measures

Name	Time	Method
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