Gout Hyperuricemia
Conditions
Interventions
Active compound: 14C enriched FYX-051, 80 mg FYX-051, 3,7 MBq (0,6 mSv) as an
oral suspension (2 mg/ml)
Sponsors
Fuji Yakuhin Co.,Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - healthy male - you are between 20 and 35 years of age; - your BMI is between 18.0 and 30.0 kg/m2 (to calculate your BMI (Body Mass Index): divide your weight (in kg) by your squared length in meters (weight / (length x length)); - you do not smoke or are a moderate smoker (please note that during your stay in the clinical research centre and in the 48h-period prior to your stay, smoking is not allowed)
Exclusion criteria
Exclusion criteria: Suffering from: hepatitis B, 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 12 months prior the start of this study. Participation is also not permitted when participated in more than 3 other drug studies in the 10 months prior to the start of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the pharmacokinetics, metabolism, and routes and extent of elimination, and to identify the metabolites of FYX-051 after a single 80 mg oral dose of 14C-FYX-051 in healthy male subjects To characterize the exposure to and the elimination of the metabolites of FX-051 in healthy male subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of a single oral 80-mg dose of 14C-FYX-051 | — |
Countries
Netherlands
Outcome results
None listed