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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01665404
First received: August 13, 2012
Last updated: August 4, 2014
Last verified: August 2014

August 13, 2012
August 4, 2014
July 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 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01665404 on ClinicalTrials.gov Archive Site
Safety: incidence of adverse events [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Effect of Fluvoxamine 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 Fluvoxamine on the Pharmacokinetics of a Single Dose RO4917523 in Healthy Subjects

This single-center, open-label, cross-over study will evaluate the effect of flu voxamine on the pharmacokinetics of RO4917523 in healthy volunteers. Healthy vol unteers will receive a single dose of RO4917523 alone and in combination with mu ltiple doses of fluvoxamine in a cross-over design. The anticipated time on stud y treatment is 40 days.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy Volunteer
  • Drug: RO4917523
    Single dose of RO4917523
  • Drug: Fluvoxamine
    Multiple doses of fluvoxamine
  • Experimental: Dosing Period 1
    Intervention: Drug: RO4917523
  • Experimental: Dosing Period 2
    Interventions:
    • Drug: RO4917523
    • Drug: Fluvoxamine
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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01665404
BP28250, 2012-000772-42
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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