Healthy, Renal ImpairmentPhase 1NCT05198778
A Safety, PK, PD and Food Effect Study of URC102 in Healthy Adults and Patients With Renal Impairment
A Phase 1 study testing URC102 in people with Healthy, Renal Impairment, run by JW Pharmaceutical at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Renal Impairment
- What is being tested?
- URC102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 29 Nov 2021to 13 Jul 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Age ≥ 19
- BMI 18.0~30.0 kg/m^2
- eGFR ≥ 90 mL/min/1.73m^2
- voluntarily given written informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chungbuk National University Hospital
Cheongju-si
Ajou University Hospital
Suwon
About this study
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
A phase 1 clinical trial to evaluate safety, PK/PD profiles and food effects of URC102 in patients with renal impairment and healthy people.
Read the 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.
- Conditions
- Healthy, Renal Impairment
- Being tested
- URC102
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
URC102Drug
tablet
URC102Drug
tablet
| Study group | Role | What they receive |
|---|---|---|
| Test group 1: Renal impairment patient | Experimental | Administer URC102, single-dose Receives: Drug: URC102 |
| Test group 2: Renal impairment patient | Experimental | Administer URC102, single-dose Receives: Drug: URC102 |
| Control group: Healthy adult people | Experimental | Administer URC102, 2 doses Receives: Drug: URC102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Pharmacodynamic parameter
Measured: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Excretion amount of uric acid
Pharmacodynamic parameter
Measured: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Number of participants with treatment-related adverse events
Safety variable
Measured: up to 2 weeks
Number of participants with clinical significant results of Physical examination
Safety variable
Measured: up to 2 weeks
Number of participants with clinical significant results of Vital signs
Safety variable
Measured: up to 2 weeks
Number of participants with clinical significant results of Laboratory tests
Safety variable
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start29 Nov 2021
- Primary completion13 Jul 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy, Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel study between groups (crossover study within healthy patients)
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min-kyu Park, MD, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198778
- Sponsor's protocol ID
- JW21102
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2021
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05198778
- Acronym / sponsor ID
- JW21102
- Conditions
- Healthy, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel study between groups (crossover study within healthy patients)
| Arm | Type | Receives |
|---|---|---|
| Test group 1: Renal impairment patient | Experimental | Drug: URC102Administer URC102, single-dose |
| Test group 2: Renal impairment patient | Experimental | Drug: URC102Administer URC102, single-dose |
| Control group: Healthy adult people | Experimental | Drug: URC102Administer URC102, 2 doses |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- For Test Group 1 and 2 - subjects with renal impairment
- Medical history
- Clinical examination
- Drug hypersensitivity and drug abuse
- For Control Group - healthy subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| URC102tablet | Drug | Control group: Healthy adult people, Test group 1: Renal impairment patient, Test group 2: Renal impairment patient |
| URC102tablet | Drug | Control group: Healthy adult people |
Primary outcome
Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
Pharmacokinetic parameter
Maximum concentration of drug in plasma (Cmax) of UR-1102
Time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours
Pharmacokinetic parameter
6 secondary outcomes
Serum uric acid
Time frame: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Excretion amount of uric acid
Time frame: 0, 2, 4, 6, 8, 10, 24, 48, 72 hours
Number of participants with treatment-related adverse events
Time frame: up to 2 weeks
Number of participants with clinical significant results of Physical examination
Time frame: up to 2 weeks
Number of participants with clinical significant results of Vital signs
Time frame: up to 2 weeks
Number of participants with clinical significant results of Laboratory tests
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min-kyu Park, MD principal investigator
Chungbuk National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing URC102 in people with Healthy, Renal Impairment, run by JW Pharmaceutical at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration-time curve from the point of administration to last time point of blood sampling (AUC) of UR-1102 (time frame: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48, 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.