NCT05198778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

8 months

First QC Date

December 16, 2021

Last Update Submit

December 4, 2022

Conditions

Healthy, Renal Impairment

Outcome Measures

Primary Outcomes (2)

  • 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

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

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

    Pharmacokinetic parameter

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

Secondary Outcomes (6)

  • Serum uric acid

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

  • Excretion amount of uric acid

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

  • Number of participants with treatment-related adverse events

    up to 2 weeks

  • Number of participants with clinical significant results of Physical examination

    up to 2 weeks

  • Number of participants with clinical significant results of Vital signs

    up to 2 weeks

  • +1 more secondary outcomes

Study Arms (3)

Test group 1: Renal impairment patient

EXPERIMENTAL

Administer URC102, single-dose

Drug: URC102

Test group 2: Renal impairment patient

EXPERIMENTAL

Administer URC102, single-dose

Drug: URC102

Control group: Healthy adult people

EXPERIMENTAL

Administer URC102, 2 doses

Drug: URC102

Interventions

URC102DRUG

tablet

Control group: Healthy adult peopleTest group 1: Renal impairment patientTest group 2: Renal impairment patient

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For Test Group 1 and 2 - subjects with renal impairment
  • Age 19\~65
  • BMI 18.0\~30.0 kg/m\^2 (Body mass index)
  • ≤ 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

URC102

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Min-kyu Park, MD

    Chungbuk National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel study between groups (crossover study within healthy patients)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 20, 2022

Study Start

November 29, 2021

Primary Completion

July 13, 2022

Study Completion

July 13, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations

KR(2)