A Single Dose Study of Radiolabeled RO4602522 in Healthy Volunteers
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This single-center, open-label study will investigate the pharmacokinetics and elimination of a radiolabelled dose of RO4602522 in healthy male volunteers. The healthy male volunteers will receive a single oral dose of RO4602522.
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Layout table for eligibility information
Ages Eligible for Study:
35 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male volunteers, 35 to 55 years of age, inclusive
Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis
A body mass index (BMI) between 18 to 30 kg/m2 inclusive
Male volunteers and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose.
Able to participate and willing to give written informed consent and to comply with the study restrictions.
Non-smokers or have not smoked since at least 3 months prior to screening
If capable of reproduction, unwilling to use an effective form of contraception
Suspicion of regular consumption of drug of abuse and/or positive drug or alcohol screen
Infection with hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2
Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg
Resting pulse rate greater than 90 or less than 45 beats per minute
Clinically significant abnormalities in laboratory test results
Participation in an investigational drug or device study within 90 days prior to screening
Donation of blood within 3 months prior to screening
Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study