Effect of Tigulixostat on the Pharmacokinetics of Theophylline

LG Chem

Status and phase: Completed; Phase 1

Conditions: Hyperuricemia; Gout

Treatments: Drug: Theophylline; Drug: Tigulixostat

Study type: Interventional

Funder types: Industry

Identifiers

NCT06189404

LG-GDCL013

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

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

Experimental group

Description:

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)

Treatment:

Drug: Tigulixostat

Drug: Theophylline