Status:
COMPLETED
A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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 P...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01495104
Start Date
October 1 2011
End Date
January 1 2012
Last Update
November 2 2016
Active Locations (1)
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1
Rueil-Malmaison, France, 92502