Healthy Volunteer
Conditions
Brief summary
This single-center, open-label study will assess the excretion balance, pharmacokinetics and metabolism of oral \[14C\]-labeled RO4917523 in healthy male volunteers. Subjects will receive a single oral dose of \[14C\]-labeled RO4917523 and an intravenous tracer dose of \[13C\]-labeled RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up to 15 weeks.
Interventions
DRUGRO4917523
\[14C\]-labeled RO4917523, single oral dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male adults, 18 to 65 years of age inclusive * Body mass index (BMI) 18.0 to 32.0 kg/m2 * Healthy, as judged by a physician on the basis of a medical history, general physical examination, laboratory tests, vital signs and 12-lead ECG * Medical history without major pathology * Agree to use two effective methods of contraception with their partners, including one barrier method (e.g. condom) throughout the study and for up to 3 months after the last dose of study drug
Exclusion criteria
* History of relevant drug and or food allergies * Smoking (within 60 days prior to drug administration until the follow-up visit) * History of alcohol abuse or drug addiction (including soft drugs like cannabis products) * Participation in a drug study within 60 days preceding first administration of study drug; participation in more than 3 other drug studies within 10 months preceding the first administration of study drug * Infrequent bowel movements (less than once per 2 days) * Participation in another ADME study with a radiation burden \>0,1 mSv in the period of 1 years before the start of the study * Positive screen for drugs of abuse * Average intake of more than 24 units of alcohol per week * Positive for hepatitis B, hepatitis C or HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Elimination: urinary and fecal recovery of total radioactivity | Pre-dose and up to approximately Day 18 post-dose |
| Plasma concentrations of RO4917523 | Pre-dose and up to approximately Day 18 post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Metabolites of RO4917523 in plasma/urine/blood pellet/feces based on radioactive metabolic profiling | Pre-dose and up to approximately Day 18 post-dose |
| Absolute bioavailability: Area under the concentration-time curve (AUC) | Pre-dose and up to approximately Day 18 post-dose |
Countries
Netherlands
Outcome results
None listed