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A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment

Primary Purpose

Healthy, Renal Impairment

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

URC102

About this trial

This is an interventional treatment trial for Healthy, Renal Impairment

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

Age 19~65
BMI 18.0~30.0 kg/m^2 (Body mass index)
30 ≤ eGFR < 60 mL/min/1.73m^2 (estimated glomerular filtration rate)
voluntarily given written informed consent

For Control Group - healthy subjects

Age ≥ 19
BMI 18.0~30.0 kg/m^2
eGFR ≥ 90 mL/min/1.73m^2
voluntarily given written informed consent

Exclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

Medical history
- Subjects with lactic acidosis or marked hepatotoxicity
- Not controlled diabetes, hypertension, dyslipidemia
- requiring dialysis
Clinical examination
- AST, ALT > 2, Bilirubin total, γ-GTP > 1.5, CK > 2 times the upper limit of normal ranges (Aspartate transaminase, Alanine transaminase, gamma-Glutamyl transpeptidase, Creatine phosphokinase)
- Positive serologic results
Drug hypersensitivity and drug abuse

For Control Group - healthy subjects

Medical history
- History of chronic liver disease, hepatic encephalopathy, ascites, or upper gastrointestinal bleeding
- Subjects with lactic acidosis or marked hepatotoxicity
Clinical examination
- AST, ALT > 2, Bilirubin total, γ-GTP > 1.5, CK > 2 times the upper limit of normal ranges
- Positive serologic results
Drug hypersensitivity and drug abuse

Sites / Locations

Chungbuk National University Hospital
Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Test group 1: Renal impairment patient

Test group 2: Renal impairment patient

Control group: Healthy adult people

Arm Description

Administer URC102, single-dose

Administer URC102, 2 doses

Outcomes

Primary Outcome Measures

Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102

Pharmacokinetic parameter

Maximum concentration of drug in plasma (Cmax) of UR-1102

Pharmacokinetic parameter

Secondary Outcome Measures

Serum uric acid

Pharmacodynamic parameter

Excretion amount of uric acid

Pharmacodynamic parameter

Number of participants with treatment-related adverse events

Safety variable

Number of participants with clinical significant results of Physical examination

Safety variable

Number of participants with clinical significant results of Vital signs

Safety variable

Number of participants with clinical significant results of Laboratory tests

Safety variable

Full Information

NCT ID

NCT05198778

First Posted

December 16, 2021

Last Updated

December 4, 2022

Sponsor

JW Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT05198778

Brief Title

A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment

Official Title

An Open, Single Dose Designed Clinical Study to Evaluate Safety and Pharmacokinetic/Pharmacodynamic Characteristics After Oral Administration of URC102 in Patients With Renal Impairment Under Fasted Conditions and Healthy Adult Volunteers Under Fasted and Fed Conditions

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

November 29, 2021 (Actual)

Primary Completion Date

July 13, 2022 (Actual)

Study Completion Date

July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

JW Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.

Detailed Description

This trial will evaluate in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of URC102 under fasted conditions. in healthy adult subjects: the safety, pharmacokinetics and pharmacodynamics of 2 single doses of URC102 in the morning after fasting or after a high-fat breakfast. The 2 doses will be separated by a washout period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Renal Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Parallel study between groups (crossover study within healthy patients)

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group 1: Renal impairment patient

Arm Type

Experimental

Arm Description

Administer URC102, single-dose

Arm Title

Test group 2: Renal impairment patient

Arm Type

Experimental

Arm Description

Administer URC102, single-dose

Arm Title

Control group: Healthy adult people

Arm Type

Experimental

Arm Description

Administer URC102, 2 doses

Intervention Type

Drug

Intervention Name(s)

URC102

Intervention Description

tablet

Intervention Type

Drug

Intervention Name(s)

URC102

Intervention Description

tablet

Primary Outcome Measure Information:

Title

Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102

Description

Pharmacokinetic parameter

Time Frame

0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours

Title

Maximum concentration of drug in plasma (Cmax) of UR-1102

Description

Pharmacokinetic parameter

Time Frame

0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours

Secondary Outcome Measure Information:

Title

Serum uric acid

Description

Pharmacodynamic parameter

Time Frame

0, 2, 4, 6, 8, 10, 24, 48, 72 hours

Title

Excretion amount of uric acid

Description

Pharmacodynamic parameter

Time Frame

0, 2, 4, 6, 8, 10, 24, 48, 72 hours

Title

Number of participants with treatment-related adverse events

Description

Safety variable

Time Frame

up to 2 weeks

Title

Number of participants with clinical significant results of Physical examination

Description

Safety variable

Time Frame

up to 2 weeks

Title

Number of participants with clinical significant results of Vital signs

Description

Safety variable

Time Frame

up to 2 weeks

Title

Number of participants with clinical significant results of Laboratory tests

Description

Safety variable

Time Frame

up to 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For Test Group 1 and 2 - subjects with renal impairment Age 19~65 BMI 18.0~30.0 kg/m^2 (Body mass index) 30 ≤ eGFR < 60 mL/min/1.73m^2 (estimated glomerular filtration rate) voluntarily given written informed consent For Control Group - healthy subjects Age ≥ 19 BMI 18.0~30.0 kg/m^2 eGFR ≥ 90 mL/min/1.73m^2 voluntarily given written informed consent Exclusion Criteria: For Test Group 1 and 2 - subjects with renal impairment Medical history Subjects with lactic acidosis or marked hepatotoxicity Not controlled diabetes, hypertension, dyslipidemia requiring dialysis Clinical examination AST, ALT > 2, Bilirubin total, γ-GTP > 1.5, CK > 2 times the upper limit of normal ranges (Aspartate transaminase, Alanine transaminase, gamma-Glutamyl transpeptidase, Creatine phosphokinase) Positive serologic results Drug hypersensitivity and drug abuse For Control Group - healthy subjects Medical history History of chronic liver disease, hepatic encephalopathy, ascites, or upper gastrointestinal bleeding Subjects with lactic acidosis or marked hepatotoxicity Clinical examination AST, ALT > 2, Bilirubin total, γ-GTP > 1.5, CK > 2 times the upper limit of normal ranges Positive serologic results Drug hypersensitivity and drug abuse

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min-kyu Park, MD

Organizational Affiliation

Chungbuk National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chungbuk National University Hospital

City

Cheongju

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment

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