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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01495104
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
3
Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice 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. Anticipated time on study is up to 12 weeks.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
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
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single Arm

Drug: RO4917838
Multiple doses

Drug: valproate
Multiple doses

Outcome Measures

Primary Outcome Measures

  1. Effect of valproate multiple-dose administration on pharmacokinetics of RO4917838 at steady-state: Area under the concentration-time curve (AUC) [Period 2, day 10 and day 15]

  2. Effect of RO4917838 multiple-dose administration on the pharmacokinetics of valproate at steady state: Area under the concentration-time curve (AUC) [Period 1, day 5 and Period 2, Day 15]

Secondary Outcome Measures

  1. Safety: Incidence of adverse events [16 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rueil-Malmaison France 92502

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01495104
Other Study ID Numbers:
  • BP25258
  • 2011-002256-14
First Posted:
Dec 19, 2011
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Valproic Acid

Study Results

No Results Posted as of Nov 2, 2016