Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGRO4602522
Single radiolabeled dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Elimination of RO4602522: urine/feces concentration | Predose, Day 1, 2 and 3 |
| Pharmacokinetics: Plasma concentration of RO4602522/metabolite | Predose, Day 1, 2 and 3 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Metabolic profile of RO4602522: plasma/urine/feces concentration | Predose, Day 1, 2 and 3 |
Countries
Netherlands
Outcome results
None listed