Alzheimer's disease dementia
Conditions
Interventions
A single dose of 60 mg radio labeled study medication in the form of an oral
capsule.
In this study radio labeled RO4602522 will be used. The amount of radioactivity
in this dose will be 2.81 MBq (M
thus the effect on the human body of the amount of radioactivity
administered). The additional radiation burden in this study due to the
administration of 2.81 MBq 14C-labeled RO4602522 is calculate
Sponsors
Hoffmann-La Roche
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: healthy male subjects 35-55 yrs, inclusive BMI: 18.0-30.0 kg/m2, inclusive non-smoking
Exclusion criteria
Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 90 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Bloodsamples for the analysis of RO4602522 and amount of radioactivity will be collected during the clinic period. Urine and feces for the analysis of RO4602522 and amount of radioactivity will be collected during the clinic period and, if required, after leaving the clinic until at maximum 20 days after dosing. | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood, urine, and feces samples for the analysis of the metabolic profile of RO4602522 will be collected during the clinic period. | — |
Countries
Netherlands
Outcome results
None listed