A Pharmacokinetic Study of RO4917838 in Healthy Chinese 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 single-center, open-label, single dose, randomized, two-way cross-over study will evaluate the pharmacokinetics, safety and tolerability of RO4917838 in healthy Chinese volunteers. Subjects will be randomized to receive a single oral dose of either 10 mg or 20 mg RO4917838 and, after a washout period of at least 21 but no more than 35 days, will be re-dosed with the alternative treatment. Anticipated time on study is up to 70 days.
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy Chinese male and female volunteers, 18 to 45 years of age inclusive at time of screening
Healthy status is defined by absence of evidence of any active or chronic disease or disorder following a detailed medical and surgical history and a complete physical examination
Body mass index (BMI) 19 to 28 kg/m2 inclusive
Pregnant or currently lactating females
History of any clinically relevant disorder
Any history of depressive episodes or treatment with antidepressants
History of drug abuse within the past 2 years or positive results for drugs of abuse at screening or Day -1
Alcohol dependence or history of this within the past 2 years or positive results for alcohol breath test at screening or Day -1
Positive for HIV, hepatitis B or hepatitis C infection
Regular smoker with consumption of more than 10 cigarettes a day or equivalent amount of tobacco
Participation in a clinical study with an investigational drug or device within the last 3 months prior to dosing