A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802
- Registration Number
- NCT01981005
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RO5424802 RO5424802 -
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802 Days 1 to 25 Elimination: Amount of drug excreted in urine/feces over the study period Days 11 to 15
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events Days 1 to 25 Pharmacokinetics: Metabolite identification in plasma, urine, and feces. Days 11 to 25