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Completed

NCT Number: NCT01368926

A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO4917523

Drug

single oral doses

Placebo

Drug

oral doses

Primary outcomes

  1. Part 1: Pharmacokinetics: Area under the concentration - time curve (AUC) (single/multiple oral dose in healthy Japanese subjects)

    Time frame: approximately 12 weeks

  2. 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

  3. Safety: Incidence of adverse events in Japanese an Caucasian subjects

    Time frame: approximately 21 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 8, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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