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CompletedNCT06189404Updated Jan 3, 2024

Effect of Tigulixostat on the Pharmacokinetics of Theophylline

A Phase 1 interventional study of Tigulixostat and Theophylline in Gout and Hyperuricemia, sponsored by LG Chem. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by LG Chem · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Nov 2023, 2 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gout
  • Hyperuricemia

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03

In context

Hyperuricemia

215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.

This study's enrollment of 24 is below the median of 64 across 172 interventional studies indexed under Hyperuricemia.

Browse Hyperuricemia studies →

Lead sponsor

LG Chem is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 1 (8%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4)

    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)

    Drug: Tigulixostat · Drug: Theophylline

Interventions

  • DrugTigulixostat

    300 mg oral dose

    Also known as: LC350189

  • DrugTheophylline

    400 mg oral dose

06

What researchers measure

Primary outcomes

  1. AUC0-t of theophylline with and without tigulixostat

    Time frame: Up to 72 hours

  2. AUC0-inf of theophylline with and without tigulixostat

    Time frame: Up to 72 hours

  3. Cmax of theophylline with and without tigulixostat

    Time frame: Up to 72 hours

Secondary outcomes

  1. Incidence of reported adverse events (AEs)

    Time frame: Up to Day 28

  2. AUC0-t of tigulixostat and metabolite GD-MET-1

    Time frame: Up to 24 hours

  3. Cmax of tigulixostat and metabolite GD-MET-1

    Time frame: Up to 24 hours

07

Study locations

1 site
  • PPD - Austin Research Unit
    Austin, Texas 78744, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06189404
Lead sponsor
LG Chem
Responsible party
Sponsor
First posted
Jan 3, 2024
Start date
Oct 31, 2023
Primary completion
Nov 13, 2023
Completion
Nov 30, 2023
Last update
Jan 3, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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