Healthy Volunteer
Conditions
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
Interventions
DRUGRO5424802
Single oral doses followed by IV or oral administration of a 14C-labeled tracer
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | Days 1 to 25 |
| Pharmacokinetics: Metabolite identification in plasma, urine, and feces. | Days 11 to 25 |
Countries
Netherlands
Outcome results
None listed