A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01495104
First received: December 15, 2011
Last updated: September 22, 2014
Last verified: September 2014

December 15, 2011
September 22, 2014
October 2011
January 2012   (final data collection date for primary outcome measure)
  • Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC) [ Time Frame: Period 2, day 10 and day 15 ] [ Designated as safety issue: No ]
  • Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC) [ Time Frame: Period 1, day 5 and Period 2, Day 15 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01495104 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: 16 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers
A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE VALPROATE ON THE PHARMACOKINETICS OF RO4917838 AND VICE VERSA IN HEALTHY MALE VOLUNTEERS

This open-label, fixed-sequence, two-period study will assess the effect of mult iple dose valproate on the pharmacokinetics of RO4917838 at steady state and vic e versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. An ticipated time on study is up to 12 weeks.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Healthy Volunteer
  • Drug: RO4917838
    Multiple doses
  • Drug: valproate
    Multiple doses
Experimental: Single Arm
Interventions:
  • Drug: RO4917838
  • Drug: valproate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male volunteers, 18 to 65 years of age inclusive
  • Body mass index (BMI) 18 to 30 kg/m2 inclusive
  • Healthy as determined by the investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs, and a 12-lead electrocardiogram (ECG)
  • Non smoker or smoker of fewer than 10 cigarettes per day

Exclusion Criteria:

  • History of alcoholism, drug abuse or addiction within the last year prior to Day -1 of the study
  • Alcohol consumption averaging more than 24 g of alcohol per day
  • History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
  • Any major illness within the 4 weeks prior to dosing or any acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of study Day -1
  • Any confirmed allergic reactions against any drug, or multiple allergies in the judgment of the investigator
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Involvement in other investigational studies of any type within 90 days of first study drug administration or within 5 times the elimination half-life of the tested drug, whichever is longer
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01495104
BP25258, 2011-002256-14
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2014

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