A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers

Study Overview
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Brief Summary
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This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.

Official Title
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Single-centre, Open-label Study Investigating the Excretion Balance, Pharmacokinetics and Metabolism of a Single Dose of 14C-labeled RO4917523 and an Intravenous Tracer Dose of 13C-labeled RO4917523 in Healthy Male Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO4917523
* Drug: RO4917523


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male adults, 18 to 65 years of age inclusive Body mass index (BMI) 18.0 to 32.0 kg/m2 Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG Medical history without major pathology Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug Exclusion Criteria: History of relevant drug and or food allergies Smoking (within 60 days prior to drug administration until the follow-up visit) History of alcohol abuse or drug addiction (including soft drugs like cannabis products) Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug Infrequent bowel movements (less than once per 2 days) Participation in another ADME study with a radiation burden >0,1 mSv in the period of 1 years before the start of the study Positive screen for drugs of abuse Average intake of more than 24 units of alcohol per week Positive for hepatitis B, hepatitis C or HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-labeled RO4917523<br> | Drug: RO4917523<br>* [14C]-labeled RO4917523, single oral dose<br>Drug: RO4917523<br>* [13C]-labeled RO4917523, single intravenous tracer dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination: urinary and fecal recovery of total radioactivity |  | Pre-dose and up to approximately Day 18 post-dose | 
| Plasma concentrations of RO4917523 |  | Pre-dose and up to approximately Day 18 post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling |  | Pre-dose and up to approximately Day 18 post-dose | 
| Absolute bioavailability: Area under the concentration-time curve (AUC) |  | Pre-dose and up to approximately Day 18 post-dose |