A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01368926
First received: May 27, 2011
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This double-blind, randomized, placebo-controlled, 2-Part study will evaluate th e pharmacokinetics and safety of RO4917523 in healthy Japanese and Caucasian vol unteers. 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 betw een dosing. In Part 2, healthy Japanese and Caucasian volunteers will be randomi zed in cohorts to receive either RO4917523 or placebo orally daily for 14 days.


Condition Intervention Phase
Healthy Volunteer
Drug: RO4917523
Drug: placebo
Phase 1

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Part 1: Pharmacokinetics: Area under the concentration - time curve (AUC) (single/multiple oral dose in healthy Japanese subjects) [ Time Frame: approximately 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events in Japanese an Caucasian subjects [ Time Frame: approximately 21 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 1 Drug: RO4917523
single oral doses
Drug: placebo
oral doses
Experimental: Part 2 Drug: RO4917523
multiple oral doses
Drug: placebo
oral doses

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368926

Locations
United States, New York
New York, New York, United States, 10016
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01368926     History of Changes
Other Study ID Numbers: BP25713
Study First Received: May 27, 2011
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014