A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

Healthy Volunteer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368926
• Other study ID #: BP25713
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2011
• Last updated: November 1, 2016
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RO4917523
single oral doses
• RO4917523
multiple oral doses
• placebo
oral doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Pharmacokinetics: Area under the concentration - time curve (AUC) (single/multiple oral dose in healthy Japanese subjects)		approximately 12 weeks	No
Primary	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	No
Primary	Safety: Incidence of adverse events in Japanese an Caucasian subjects		approximately 21 weeks	No