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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629368
First Posted: June 27, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
June 25, 2012
June 27, 2012
November 2, 2016
June 2012
September 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01629368 on ClinicalTrials.gov Archive Site
Safety: incidence of adverse events [ Time Frame: 6 weeks ]
Same as current
Not Provided
Not Provided
 
A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Healthy Volunteer
  • Drug: Carbamazepine
    Multiple doses of carbamazepine
  • Drug: RO4917523
    Single dose of RO4917523
  • Experimental: Dosing Period 1
    Intervention: Drug: RO4917523
  • Experimental: Dosing Period 2
    Interventions:
    • Drug: Carbamazepine
    • Drug: RO4917523
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01629368
BP28256
2012-000771-16 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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