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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: RO5424802

Study type

Interventional

Funder types

Industry

Identifiers

NCT01981005

NP28989

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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