Effect of Tigulixostat on the Pharmacokinetics of Theophylline

• Status: Completed
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: LG Chem
• Treatments: Theophylline

Criteria

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.