D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, and Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics; Including an Open-label Cohort to Determine the Effect of Food on the Pharmacokinetics of D-0120-NA Tablet in Healthy Volunteers in the United States

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 Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: D-0120

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Daytona Beach Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-0120 Dose 1; D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation	Drug: D-0120; oral, single dose
Experimental: D-0120 Dose 2; D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation	Drug: D-0120; oral, single dose
Experimental: D-0120 Dose 3; D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation	Drug: D-0120; oral, single dose
Experimental: D-0120 Dose 4; D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation	Drug: D-0120; oral, single dose
Experimental: D-0120 Dose 5; D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state.	Drug: D-0120; oral, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)	AUC: area under the plasma concentration versus time curve for D-0120	Day-1 through 3
Pharmacokinetic: maximum plasma drug concentration (Cmax)	Cmax: maximum plasma drug concentration of D-0120	Day-1 through 3
Pharmacokinetic: Time to reach the Cmax (Tmax)	Tmax: Time to reach the Cmax of D-0120	Day-1 through 3
Pharmacokinetic: Apparent terminal half-life (t1/2)	t1/2: apparent terminal half-life of D-0120	Day-1 through 3
Pharmacokinetic: Apparent oral clearance (CL/F)	CL/F: Apparent oral clearance of D-0120	Day-1 through 3
Pharmacokinetic: Apparent volume of distribution (Vz/F)	Vz/F: Apparent volume of distribution of D-0120	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 %)	Day-1 through 3

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2017
• Primary Completion (Actual): April 6, 2018
• Study Completion (Actual): August 6, 2018

Study Registration Dates

• First Submitted: September 14, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 16, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IBIO-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No