GoutPhase 1NCT04139824
The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
A Phase 1 study testing Xanthine Oxidase Inhibitor and nonsteroidal anti-inflammatory drug 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, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in combination in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Xanthine Oxidase Inhibitor and nonsteroidal anti-inflammatory drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 25 Feb 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject is male or female 18 to 50 years of age, inclusive.
- The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
- The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening.
- The subject agrees to comply with all protocol requirements.
- The subject is able to provide written informed consent.
Who cannot join
- The subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator.
- The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
- The subject has an estimated glomerular filtration rate (eGFR) of <90 (mL/min)/1.73 m2.
- The subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study.
- The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study.
- The subject is a smoker or has used nicotine or nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6 months before the first dose of study drug.
- The subject has a history of alcohol abuse or drug addiction within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
- The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Fixed-sequence, 2-way Drug Interaction Study to Evaluate the Effect of Naproxen on the Pharmacokinetics of LC350189 and the Effect of LC350189 on the Pharmacokinetics of Naproxen in Healthy Subjects
This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in combination in healthy subjects.
- Conditions
- Gout, Hyperuricemia
- Being tested
- Xanthine Oxidase Inhibitor, nonsteroidal anti-inflammatory drug
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanthine Oxidase InhibitorDrug
Also called LC350189
LC350189 200mg qd
nonsteroidal anti-inflammatory drugDrug
Also called Naproxen
Naproxen 500mg BID
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Experimental | Period 1: LC350189 200mg (QD) Day 1~ Day 4, Period 2: Naproxen 500 mg (BID) Day 8 ~ Day 12 , Period 3 : LC350189 200mg (QD) + Naproxen 500 mg (BID) Day 13~19 Receives: Drug: Xanthine Oxidase Inhibitor; Drug: nonsteroidal anti-inflammatory drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma
Pharmacokinetic
Measured: From baseline up to Day 18
Area under the concentration-time curve (AUC) of LC350189 and Naproxen from plasma
Pharmacokinetic
Measured: From baseline up to Day 18
Apparent terminal half-life (t1/2) of LC350189 and Naproxen from plasma
Pharmacokinetic
Measured: From baseline up to Day 18
Secondary outcomes (2)
Incidence of Adverse events
Safety
Measured: From baseline up to Day 18
Changes in concentration of uric acid in plasma by uricase method
Pharmacodynamic
Measured: From baseline up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start22 Jan 2020
- Primary completion25 Feb 2020
- Study completion25 Feb 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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT04139824
- Sponsor's protocol ID
- LG-GDCL006
- Status last verified
- Jun 2020
- First submitted
- 21 Oct 2019
- Last updated
- 26 Jun 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 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Fixed-sequence, 2-way Drug Interaction Study to Evaluate the Effect of Naproxen on the Pharmacokinetics of LC350189 and the Effect of LC350189 on the Pharmacokinetics of Naproxen in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04139824
- Acronym / sponsor ID
- LG-GDCL006
- Conditions
- Gout, Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 25 Oct 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, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in combination in healthy subjects.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Experimental | Drug: Xanthine Oxidase Inhibitor, Drug: nonsteroidal anti-inflammatory drugPeriod 1: LC350189 200mg (QD) Day 1~ Day 4, Period 2: Naproxen 500 mg (BID) Day 8 ~ Day 12 , Period 3 : LC350189 200mg (QD) + Naproxen 500 mg (BID) Day 13~19 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject is male or female 18 to 50 years of age, inclusive.
- The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
- The subject is judged by the investigator to be in good general health, as determined by medical history, clinical laboratory assessments, vital sign measurements, 12 lead electrocardiogram (ECG) results, and physical examination findings at screening.
- The subject agrees to comply with all protocol requirements.
- The subject is able to provide written informed consent.
Key exclusion criteria (8 listed)
- The subject has a medical history with any issues affecting absorption or metabolism, as judged by the investigator.
- The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
- The subject has an estimated glomerular filtration rate (eGFR) of <90 (mL/min)/1.73 m2.
- The subject has used any prescription (excluding hormonal birth control and hormone replacement therapy) or over the counter medications (except paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug or throughout the study.
- The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange containing products (eg, marmalade), or caffeine- or xanthine containing products within 48 hours before the first dose of study drug or throughout the study.
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 |
|---|---|---|
| Xanthine Oxidase InhibitorAlso: LC350189LC350189 200mg qd | Drug | Cohort |
| nonsteroidal anti-inflammatory drugAlso: NaproxenNaproxen 500mg BID | Drug | Cohort |
Primary outcome
Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma
Time frame: From baseline up to Day 18
Pharmacokinetic
Area under the concentration-time curve (AUC) of LC350189 and Naproxen from plasma
Time frame: From baseline up to Day 18
Pharmacokinetic
Apparent terminal half-life (t1/2) of LC350189 and Naproxen from plasma
Time frame: From baseline up to Day 18
Pharmacokinetic
2 secondary outcomes
Incidence of Adverse events
Time frame: From baseline up to Day 18
Changes in concentration of uric acid in plasma by uricase method
Time frame: From baseline up to Day 17
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 26 Jun 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 Xanthine Oxidase Inhibitor and nonsteroidal anti-inflammatory drug 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 8 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 26 Jun 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?
Maximun observed concentration (Cmax) of LC350189 and Naproxen from plasma (time frame: From baseline up to Day 18). The study lists 3 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 26 Jun 2020.