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

Sponsor

InventisBio Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03291782

Collaborator

(none)

Enrollment

Location

Arms

10.7

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gout	Drug: D-0120	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 13, 2017

Actual Primary Completion Date :

Apr 6, 2018

Actual Study Completion Date :

Aug 6, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [2 weeks]
Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs

Secondary Outcome Measures

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 terminal half-life (t1/2) [Day-1 through 3]
t1/2: apparent terminal half-life of D-0120
Pharmacokinetic: Apparent oral clearance (CL/F) [Day-1 through 3]
CL/F: Apparent oral clearance of 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 %)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Daytona Beach Clinical Research Unit	Daytona Beach	Florida	United States	32117

Sponsors and Collaborators

InventisBio Co., Ltd

Investigators

Principal Investigator: Hugh Coleman, MD, Covance

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

InventisBio Co., Ltd

ClinicalTrials.gov Identifier:

NCT03291782

Other Study ID Numbers:

IBIO-201

First Posted:

Sep 25, 2017

Last Update Posted:

Dec 19, 2018

Last Verified:

Jun 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 19, 2018