Gout
Conditions
Brief summary
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.
Interventions
DRUGD-0120
oral, single dose
Sponsors
InventisBio Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be medically documented as healthy and acceptable at physical examination. * Subjects serum uric acid level at screening ≥ 4.5 mg/dL. * Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or higher * Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator. * Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator. * Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
Exclusion criteria
* Any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders. * Any history or suspicion of kidney stones. * Positive for HIV, Hepatitis B, and/or Hepatitis C. * Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing. * Undergone major surgery within 3 months prior to Day 1. * Women who are pregnant or breastfeeding. * Subjects who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing. * Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration. * Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 2 weeks | Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic: maximum plasma drug concentration (Cmax) | Day-1 through 3 | Cmax: maximum plasma drug concentration of D-0120 |
| Pharmacokinetic: Time to reach the Cmax (Tmax) | Day-1 through 3 | Tmax: Time to reach the Cmax of D-0120 |
| Pharmacokinetic: Apparent terminal half-life (t1/2) | Day-1 through 3 | t1/2: apparent terminal half-life of D-0120 |
| Pharmacokinetic: area under the plasma concentration versus time curve (AUC) | Day-1 through 3 | AUC: area under the plasma concentration versus time curve for D-0120 |
| Pharmacokinetic: Apparent volume of distribution (Vz/F) | Day-1 through 3 | Vz/F: Apparent volume of distribution of D-0120 |
| PD profile of D-0120 from plasma and urine | Day-1 through 3 | 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 %) |
| Pharmacokinetic: Apparent oral clearance (CL/F) | Day-1 through 3 | CL/F: Apparent oral clearance of D-0120 |
Countries
United States
Outcome results
None listed