Clinical trial NCT01981005: A Study of the Elimination, Pharmacokinetics, and Metabolism of RO5424802
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-11-11
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Elimination: Amount of drug excreted in urine/feces over the study period
timeFrame: Days 11 to 15
measure: Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802
timeFrame: Days 1 to 25
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: Days 1 to 25
measure: Pharmacokinetics: Metabolite identification in plasma, urine, and feces.
timeFrame: Days 11 to 25
Other outcomes:
Locations:
city: Zuidlaren
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: