GoutPhase 1NCT06189404
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
A Phase 1 study testing Tigulixostat and Theophylline in people with Gout and Hyperuricemia, run by LG Chem at 1 site in United States.
Trial summary
A phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Gout, Hyperuricemia
- What is being tested?
- Tigulixostat and Theophylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 30 Nov 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, Ages 18 to 55, inclusive.
- BMI 18.0 - 32.0 kg/m2, inclusive, at screening.
- In good general health as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- Females of childbearing potential and males who agree to use contraception. Non-pregnant, non-lactating females who must have a negative pregnancy test at screening and check-in.
Who cannot join
- Significant history or indications of ill-health, as judged by the investigator.
- Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
- eGFRcr of <60 (mL/min)/1.73 m2 at screening.
- alanine aminotransferase, aspartate aminotransferase, or total bilirubin ≥2 times the upper limit of normal at screening and check-in.
- Used any prescription or over-the-counter medications (except acetaminophen [Tylenol] up to 2 g per day), including herbal or nutritional supplements, within 14 days before the first dose of study drug.
- 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.
- History of hypersensitivity to theophylline or other xanthines and tigulixostat.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Oral Doses of Tigulixostat on the Pharmacokinetics of a Single Oral Dose of Theophylline
A phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers.
- Conditions
- Gout, Hyperuricemia
- Being tested
- Tigulixostat, Theophylline
- Medical subject headings
- Gout, Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigulixostatDrug
Also called LC350189
300 mg oral dose
TheophyllineDrug
400 mg oral dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4) | Experimental | Period 1: Single oral dose of theophylline (Day 1); Period 2: Once-daily oral doses of tigulixostat (Days 6 to 10); Period 3: Once-daily oral doses of tigulixostat (Days 11 to 13) and a single oral dose of theophylline (Day 11); Period 4: Single oral dose of tigulixostat (Day 19) Receives: Drug: Tigulixostat; Drug: Theophylline |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t of theophylline with and without tigulixostat
Measured: Up to 72 hours
AUC0-inf of theophylline with and without tigulixostat
Measured: Up to 72 hours
Cmax of theophylline with and without tigulixostat
Measured: Up to 72 hours
Secondary outcomes (3)
Incidence of reported adverse events (AEs)
Measured: Up to Day 28
AUC0-t of tigulixostat and metabolite GD-MET-1
Measured: Up to 24 hours
Cmax of tigulixostat and metabolite GD-MET-1
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start31 Oct 2023
- Primary completion13 Nov 2023
- Study completion30 Nov 2023
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- NCT06189404
- Sponsor's protocol ID
- LG-GDCL013
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Oral Doses of Tigulixostat on the Pharmacokinetics of a Single Oral Dose of Theophylline
- ClinicalTrials.gov ID
- NCT06189404
- Acronym / sponsor ID
- LG-GDCL013
- 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
- 31 Oct 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 3 Jan 2024 (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, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4) | Experimental | Drug: Tigulixostat, Drug: TheophyllinePeriod 1: Single oral dose of theophylline (Day 1); Period 2: Once-daily oral doses of tigulixostat (Days 6 to 10); Period 3: Once-daily oral doses of tigulixostat (Days 11 to 13) and a single oral dose of theophylline (Day 11); Period 4: Single oral dose of tigulixostat (Day 19) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female, Ages 18 to 55, inclusive.
- BMI 18.0 - 32.0 kg/m2, inclusive, at screening.
- In good general health as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead ECG results, and physical examination findings at screening.
- Females of childbearing potential and males who agree to use contraception. Non-pregnant, non-lactating females who must have a negative pregnancy test at screening and check-in.
Key exclusion criteria (7 listed)
- Significant history or indications of ill-health, as judged by the investigator.
- Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
- eGFRcr of <60 (mL/min)/1.73 m2 at screening.
- alanine aminotransferase, aspartate aminotransferase, or total bilirubin ≥2 times the upper limit of normal at screening and check-in.
- Used any prescription or over-the-counter medications (except acetaminophen [Tylenol] up to 2 g per day), including herbal or nutritional supplements, within 14 days before the first dose of study drug.
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 |
|---|---|---|
| TigulixostatAlso: LC350189300 mg oral dose | Drug | Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4) |
| Theophylline400 mg oral dose | Drug | Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4) |
Primary outcome
AUC0-t of theophylline with and without tigulixostat
Time frame: Up to 72 hours
AUC0-inf of theophylline with and without tigulixostat
Time frame: Up to 72 hours
Cmax of theophylline with and without tigulixostat
Time frame: Up to 72 hours
3 secondary outcomes
Incidence of reported adverse events (AEs)
Time frame: Up to Day 28
AUC0-t of tigulixostat and metabolite GD-MET-1
Time frame: Up to 24 hours
Cmax of tigulixostat and metabolite GD-MET-1
Time frame: Up to 24 hours
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 3 Jan 2024.
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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 Tigulixostat and Theophylline 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 4 inclusion and 7 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 3 Jan 2024. 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?
AUC0-t of theophylline with and without tigulixostat (time frame: Up to 72 hours). 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 3 Jan 2024.