A Pharmacokinetic Study of RO4917523 in Healthy Japanese and Caucasian Subjects

NCT01368926 | Completed Phase 1

• 1 other identifier: BP25713
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (3)

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

  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

  approximately 9 weeks

• Safety: Incidence of adverse events in Japanese an Caucasian subjects

  approximately 21 weeks

Study Arms (2)

Part 1

EXPERIMENTAL

Drug: RO4917523; Drug: placebo

Part 2

EXPERIMENTAL

Drug: RO4917523; Drug: placebo

Interventions

RO4917523 DRUG

single oral doses

Part 1

placebo DRUG

oral doses

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

2-chloro-4-(1-(4-fluorophenyl)-2,5-dimethyl-1H-imidazol-4-ylethynyl)pyridine

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 8, 2011
• Study Start: June 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)