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A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers
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.
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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.
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 ]
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 ]
Secondary Outcome Measures
Safety: Incidence of adverse events [ Time Frame: 16 days ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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