A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects
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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.
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.
Part 1: Pharmacokinetics: Area under the concentration - time curve (AUC) (single/multiple oral dose in healthy Japanese subjects) [ Time Frame: 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 [ Time Frame: approximately 9 weeks ]
Safety: Incidence of adverse events in Japanese an Caucasian subjects [ Time Frame: approximately 21 weeks ]
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Ages Eligible for Study:
18 Years to 50 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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