A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO4917523

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01368926

BP25713

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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