stroke
Conditions
Interventions
The volunteer will receive a single dose of 180 milligrams (mg) radiolabeled S
44819 as an oral suspension
the suspension is a liquid with undissolved
powder.
S 44819
Sponsors
Institut de Recherches Internationales Servier (I.R.I.S.)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - healthy male caucasian participants aged between 18-45 years inclusively - 18.5 kg/m²*BMI* 30.0 kg/m² - Body weight * 50 kg - Be a non-smoker (or having not smoked for at least 6 months prior to the selection visit)
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. Donation of blood derivates or loss of more than 50 mL of blood within the 90 days before the day of selection, during the study and 3 months following completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the excretion balance of total radioactivity in urine and faeces after administration of a single oral dose of 180 mg of S 44819 containing 1.58 MBq of [14C]-S 44819 in fasting conditions. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess after administration of a single oral dose of 180 mg of S 44819 containing 1.58 MBq of [14C]-S 44819 in fasting conditions: - The pharmacokinetics of the total radioactivity in blood and plasma - The pharmacokinetics of S 44819 in plasma - The metabolite profile of S 44819 in plasma, urine and faeces - The safety of S 44819 | — |
Countries
The Netherlands
Outcome results
None listed