Clinical trial NCT05198778: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy, Renal Impairment
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study between groups (crossover study within healthy patients)
Primary purpose: TREATMENT

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

1. in patients with renal impairment: the safety, pharmacokinetics and pharmacodynamics after single oral administration of URC102 under fasted conditions.
2. 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.

Eligibility criteria: Inclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

1. Age 19\~65
2. BMI 18.0\~30.0 kg/m\^2 (Body mass index)
3. 30 ≤ eGFR \< 60 mL/min/1.73m\^2 (estimated glomerular filtration rate)
4. voluntarily given written informed consent

For Control Group - healthy subjects

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

Exclusion Criteria:

For Test Group 1 and 2 - subjects with renal impairment

1. Medical history

   * Subjects with lactic acidosis or marked hepatotoxicity
   * Not controlled diabetes, hypertension, dyslipidemia
   * requiring dialysis
2. 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
3. Drug hypersensitivity and drug abuse

For Control Group - healthy subjects

1. Medical history

   * History of chronic liver disease, hepatic encephalopathy, ascites, or upper gastrointestinal bleeding
   * Subjects with lactic acidosis or marked hepatotoxicity
2. Clinical examination

   * AST, ALT \> 2, Bilirubin total, γ-GTP \> 1.5, CK \> 2 times the upper limit of normal ranges
   * Positive serologic results
3. Drug hypersensitivity and drug abuse

Primary outcomes:
measure: Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
measure: Maximum concentration of drug in plasma (Cmax) of UR-1102
timeFrame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
Secondary outcomes:
measure: Serum uric acid
timeFrame: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
measure: Excretion amount of uric acid
timeFrame: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
measure: Number of participants with treatment-related adverse events
timeFrame: up to 2 weeks
measure: Number of participants with clinical significant results of Physical examination
timeFrame: up to 2 weeks
measure: Number of participants with clinical significant results of Vital signs
timeFrame: up to 2 weeks
measure: Number of participants with clinical significant results of Laboratory tests
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Chungbuk National University Hospital
name: Min-kyu Park, MD
role: PRINCIPAL_INVESTIGATOR
References: