Healthy volunteers
Conditions
Sponsors
TEIJIN PHARMA LIMITED
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subjects will be males, any ethnic origin and between 18 and 60 years of age, inclusive Subjects will have a BMI between 18.0 and 32.0 kg/m2, inclusive and body weight between 50 and 100 kg, inclusive Subjects will be in good health, as determined by medical history, physical examination, vital signs assessment, 12-lead ECG and clinical laboratory evaluations Subjects will have a screening sUA level > 5 mg/dL
Exclusion criteria
Exclusion criteria: Subjects who consume more than 28 units of alcohol per week Subjects who have a significant history of alcoholism or drug/chemical abuse Subjects who smoke more than 5 cigarettes or use the equivalent in tobacco per day Subjects with a creatinine clearance < 80 mL/min at screening Subjects who, in the opinion of the Investigator, should not participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse Events, vital signs, ECGs and Clinical laboratory evaluations Part A: Day -2, 48 hrs after dose, 6 - 8 days post final dose Part B: Day -2, Days 1 and 5: Predose, Day 10: Predose and 48 hours postdose, 6 - 8 days post final dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: blood and urine PK , Part B: blood PK Pharmcodynamics: blood and urine uric acid concentrations PK: [Time frame: Day 1 to after 72 hrs final dose] PD: [Time frame: pre to 6 - 8 days post final dose] | — |
Outcome results
None listed