A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

Overview

This single-center, open-label, cross-over study will evaluate the effect of carbamazepine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a single dose of RO4917523 alone and in combination with multiple doses of carbamazepine in a cross-over design. The anticipated time on study treatment is 40 days.

Full Title of Study: “A Single-Center, Open-Label, One-Sequence, Crossover Study to Investigate the Effects of Multiple Doses of Carbamazepine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: Carbamazepine
    • Multiple doses of carbamazepine
  • Drug: RO4917523
    • Single dose of RO4917523

Arms, Groups and Cohorts

  • Experimental: Dosing Period 1
  • Experimental: Dosing Period 2

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics: Area under the concentration time curve
    • Time Frame: Period 1: Pre-dose and up to Day 14, Period 2: Pre-dose and up to Day 29

Secondary Measures

  • Safety: incidence of adverse events
    • Time Frame: 6 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy volunteers, 18-65 years of age inclusive – Non-smokers – Body mass index (BMI) between 18 and 30 mg/m2 inclusive – Women who are not menopausal or surgically sterile agree to use two adequate methods of contraception Exclusion Criteria:

  • Evidence of any active or chronic disease – History of any significant disease (e.g., cardiovascular, hepatic, renal) or cancer – History or presence of clinically significant psychiatric condition – Any condition or disease that would render the volunteer unsuitable for the study, place the volunteer at undue risk or interfere with the ability of the volunteer to complete the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hoffmann-La Roche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trials, Study Director, Hoffmann-La Roche

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