A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01368926
• Date of registration: 27/05/2011
• Primary sponsor: Hoffmann-La Roche
• Public title: A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects
• Scientific 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.
• Date of first enrolment: June 2011
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01368926
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Countries of recruitment

United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Volunteer

Intervention(s)

Drug: placebo

Drug: RO4917523

Primary Outcome(s)

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]

Secondary ID(s)

BP25713

Source(s) of Monetary Support

Please refer to primary and secondary sponsors