GoutPhase 1NCT04066712
Renal PK Study of LC350189
A Phase 1 study testing LC350189 200 mg in people with Gout and Hyperuricemia, run by LG Chem at 1 site in United States.
Trial summary
This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- LC350189 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 12 Sep 2020
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject has a BMI of 18 to 40 kg/m2, inclusive, at screening.
- The subject is able to provide written informed consent.
- For healthy subjects only : The subject has normal renal function as determined by eGFR and calculated using the MDRD formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.
- For subjects with renal impairment only
- : The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.
Who cannot join
- The subject has a history or clinical manifestations of a significant neurological, cardiovascular, endocrine, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- The subject has nephrotic syndrome, defined as serum albumin <3.0 g/dL and urine protein/creatinine ratio >350 mg/mmol (as an estimate of approximate proteinuria of >3.5 g/day) at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LC350189 in Subjects With Varying Degrees of Renal Impairment
This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.
- Conditions
- Gout, Hyperuricemia
- Being tested
- LC350189 200 mg
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LC350189 200 mgDrug
Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
| Study group | Role | What they receive |
|---|---|---|
| A: Normal (control) renal function | Experimental | Not described Receives: Drug: LC350189 200 mg |
| B: Mild impairment renal function | Experimental | Not described Receives: Drug: LC350189 200 mg |
| C: Moderate impairment renal function | Experimental | Not described Receives: Drug: LC350189 200 mg |
| D: Severe impairment renal function | Experimental | Not described Receives: Drug: LC350189 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from time 0 to the last quantifiable concentration
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
AUC from time 0 to 24 hours post dose
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
AUC from time 0 to the end of the dosing interval at steady state
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
Maximum observed plasma concentration
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
Maximum observed plasma concentration at steady state
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
Time to reach maximum observed plasma concentration
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
Time to reach maximum observed plasma concentration at steady state
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
Amount of drug excreted in urine (Ae) over each collection interval
Pharmacokinetic Assessments
Measured: Before dosing on Days 1 through Day 8
Secondary outcomes (4)
Serum mean concentration over 24 hours
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Measured: Before dosing on Days 1 through Day 8
Maximum observed effect
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Measured: Before dosing on Days 1 through Day 8
Time to reach maximum effect
Pharmacodynamic Assessments (uric acid, xanthine, and hypoxanthine)
Measured: Before dosing on Days 1 through Day 8
Incidence of adverse events
Safety
Measured: Days 1 through Day 9 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start19 Nov 2019
- Primary completion12 Sep 2020
- Study completion12 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies 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
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066712
- Sponsor's protocol ID
- LG-GDCL003
- Status last verified
- Nov 2019
- First submitted
- 20 Aug 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LC350189 in Subjects With Varying Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT04066712
- Acronym / sponsor ID
- LG-GDCL003
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 26 Aug 2019 (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.
This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: Normal (control) renal function | Experimental | Drug: LC350189 200 mg |
| B: Mild impairment renal function | Experimental | Drug: LC350189 200 mg |
| C: Moderate impairment renal function | Experimental | Drug: LC350189 200 mg |
| D: Severe impairment renal function | Experimental | Drug: LC350189 200 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject has a BMI of 18 to 40 kg/m2, inclusive, at screening.
- The subject is able to provide written informed consent.
- For healthy subjects only : The subject has normal renal function as determined by eGFR and calculated using the MDRD formula, or by 24-hour urine creatinine clearance (CLcr) corrected for body size.
- For subjects with renal impairment only
- : The subject has mild, moderate, or severe renal impairment as determined by eGFR and calculated using the MDRD formula.
Key exclusion criteria (2 listed)
- The subject has a history or clinical manifestations of a significant neurological, cardiovascular, endocrine, gastrointestinal, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- The subject has nephrotic syndrome, defined as serum albumin <3.0 g/dL and urine protein/creatinine ratio >350 mg/mmol (as an estimate of approximate proteinuria of >3.5 g/day) at screening.
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 |
|---|---|---|
| LC350189 200 mgStudy drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7 | Drug | A: Normal (control) renal function, B: Mild impairment renal function, C: Moderate impairment renal function, D: Severe impairment renal function |
Primary outcome
AUC from time 0 to the last quantifiable concentration
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
AUC from time 0 to 24 hours post dose
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
AUC from time 0 to the end of the dosing interval at steady state
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Maximum observed plasma concentration
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Maximum observed plasma concentration at steady state
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Time to reach maximum observed plasma concentration
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Time to reach maximum observed plasma concentration at steady state
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
Amount of drug excreted in urine (Ae) over each collection interval
Time frame: Before dosing on Days 1 through Day 8
Pharmacokinetic Assessments
4 secondary outcomes
Serum mean concentration over 24 hours
Time frame: Before dosing on Days 1 through Day 8
Maximum observed effect
Time frame: Before dosing on Days 1 through Day 8
Time to reach maximum effect
Time frame: Before dosing on Days 1 through Day 8
Incidence of adverse events
Time frame: Days 1 through Day 9 (end of study)
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 21 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LC350189 200 mg in people with Gout and Hyperuricemia, run by LG Chem at 1 site in United States.
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 5 inclusion and 2 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
AUC from time 0 to the last quantifiable concentration (time frame: Before dosing on Days 1 through Day 8). The study lists 8 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 21 Sep 2020.