D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
- Registration Number
- NCT03291782
- Lead Sponsor
- InventisBio Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description D-0120 Dose 4 D-0120 D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation D-0120 Dose 1 D-0120 D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation D-0120 Dose 2 D-0120 D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation D-0120 Dose 3 D-0120 D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation D-0120 Dose 5 D-0120 D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events 2 weeks Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs
- Secondary Outcome Measures
Name Time Method 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: 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 oral clearance (CL/F) Day-1 through 3 CL/F: Apparent oral clearance 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 volume of distribution (Vz/F) Day-1 through 3 Vz/F: Apparent volume of distribution of D-0120
Trial Locations
- Locations (1)
Covance Daytona Beach Clinical Research Unit
🇺🇸Daytona Beach, Florida, United States