Effect of Tigulixostat on the Pharmacokinetics of Theophylline

Phase 1

Completed

• Conditions: Hyperuricemia; Gout
• Interventions: Drug: Tigulixostat; Drug: Theophylline

• Registration Number: NCT06189404
• Lead Sponsor: LG Chem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-31
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4)	Tigulixostat	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)
Cohort 1 (Periods 1-3), Cohort 2 (Periods 1-4)	Theophylline	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

PPD - Austin Research Unit; 🇺🇸 Austin, Texas, United States