A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802

Study Overview
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Brief Summary
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This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers

Official Title
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A PHASE 1, SINGLE-CENTER, OPEN-LABEL STUDY INVESTIGATING THE EXCRETION BALANCE, PHARMACOKINETICS AND METABOLISM OF A SINGLE ORAL DOSE AND PHARMACOKINETICS OF AN INTRAVENOUS TRACER OF [14-C]-RO5424802 IN HEALTHY MALE SUBJECTS

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RO5424802


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male adults, 18 to 45 years of age, inclusive Body mass index (BMI) from 18 to 32 kg/m2, inclusive Willingness to use effective contraception as outlined in the protocol Willingness to abstain from alcohol and xanthine-containing beverages or food (coffee, tea, cola, chocolate and energy drinks) from 72 hours prior to the first dose until discharged Willingness to avoid prolonged sun exposure and guard against sunburn during study & follow-up Exclusion Criteria: Clinically significant medical history or findings in physical examination, vital signs, or laboratory test results prior to study start Positive screening tests for hepatitis B or C, HIV, alcohol, drugs of abuse, or tobacco Regular smoking within 6 months prior to first dosing. Subjects should avoid smoky environments for at least 1 week prior to each cotinine screen Excessive alcohol consumption Use of any metabolic inducers (including herbals such as St. John's Wort) within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study medication, including but not limited to: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin and phenobarbital Regular work with ionizing radiation or radioactive material Subjects enrolled in a previous radiolabel study or who have received radiotherapy within 12 months prior to first dosing such that total radioactivity over a 12 month period would exceed an acceptable radiation burden > 0.1 mSv Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or participation in a medical trial in the previous year Strenuous activity, sunbathing, or contact sports are not allowed from 4 days prior to entry into the clinical site until study follow-up Participation in an investigational drug or device study within 60 days (or 6 months for biologic therapies) prior to first dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RO5424802<br> | Drug: RO5424802<br>* Single oral doses followed by IV or oral administration of a 14C-labeled tracer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elimination: Amount of drug excreted in urine/feces over the study period |  | Days 11 to 15 | 
| Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802 |  | Days 1 to 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | Days 1 to 25 | 
| Pharmacokinetics: Metabolite identification in plasma, urine, and feces. |  | Days 11 to 25 |