Zuidlaren, 9471 GP, Netherlands
NCT Number: NCT01981005
A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802
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
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Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
RO5424802
DrugSingle oral doses followed by IV or oral administration of a 14C-labeled tracer
Primary outcomes
-
Elimination: Amount of drug excreted in urine/feces over the study period
Time frame: Days 11 to 15
-
Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802
Time frame: Days 1 to 25
Secondary outcomes
-
Safety: Incidence of adverse events
Time frame: Days 1 to 25
-
Pharmacokinetics: Metabolite identification in plasma, urine, and feces.
Time frame: Days 11 to 25
Sponsors and collaborators
Lead sponsor
Hoffmann-La Roche
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Nov 11, 2013
- Registry last updated
- Nov 2, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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