Effect of Tigulixostat on the Pharmacokinetics of Theophylline

NCT06189404 | Completed Phase 1 FDA Drug

• 1 other identifier: LG-GDCL013
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (3)

• AUC0-t of theophylline with and without tigulixostat

  Up to 72 hours

• AUC0-inf of theophylline with and without tigulixostat

  Up to 72 hours

• Cmax of theophylline with and without tigulixostat

  Up to 72 hours

Secondary Outcomes (3)

• Incidence of reported adverse events (AEs)

  Up to Day 28

• AUC0-t of tigulixostat and metabolite GD-MET-1

  Up to 24 hours

• Cmax of tigulixostat and metabolite GD-MET-1

  Up to 24 hours

Study Arms (1)

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)

Drug: Tigulixostat; Drug: Theophylline

Interventions

Tigulixostat DRUG

300 mg oral dose

Also known as: LC350189

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

Theophylline DRUG

400 mg oral dose

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

PPD - Austin Research Unit

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

Theophylline

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 3, 2024
• Study Start: October 31, 2023
• Primary Completion: November 13, 2023
• Study Completion: November 30, 2023
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

US (1)