This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs). In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
oral, single dose
Covance Daytona Beach Clinical Research Unit
Daytona Beach, Florida, United States
Incidence of Treatment-Emergent Adverse Events
Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs
Time frame: 2 weeks
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
AUC: area under the plasma concentration versus time curve for D-0120
Time frame: Day-1 through 3
Pharmacokinetic: maximum plasma drug concentration (Cmax)
Cmax: maximum plasma drug concentration of D-0120
Time frame: Day-1 through 3
Pharmacokinetic: Time to reach the Cmax (Tmax)
Tmax: Time to reach the Cmax of D-0120
Time frame: Day-1 through 3
Pharmacokinetic: Apparent terminal half-life (t1/2)
t1/2: apparent terminal half-life of D-0120
Time frame: Day-1 through 3
Pharmacokinetic: Apparent oral clearance (CL/F)
CL/F: Apparent oral clearance of D-0120
Time frame: Day-1 through 3
Pharmacokinetic: Apparent volume of distribution (Vz/F)
Vz/F: Apparent volume of distribution of D-0120
Time frame: Day-1 through 3
PD profile of D-0120 from plasma and urine
Profile in terms of Serum uric acid and creatinine; Urine uric acid and creatinine. These parameters will be combined to report fractional excretion of uric acid (FEUa %)
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Time frame: Day-1 through 3