Effect of Tigulixostat on the Pharmacokinetics of Theophylline

Last updated: December 18, 2023
Sponsor: LG Chem
Overall Status: Completed

Phase

1

Condition

Gout (Hyperuricemia)

Joint Injuries

Collagen Vascular Diseases

Treatment

Tigulixostat

Theophylline

Clinical Study ID

NCT06189404
LG-GDCL013
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 laboratoryassessments, vital sign measurements, 12-lead ECG results, and physical examinationfindings 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 atscreening and check-in.

Exclusion

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 theupper 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 beforethe first dose of study drug.
  • Consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containingproducts (eg, marmalade), or caffeine- or xanthine-containing products within 48 hoursbefore the first dose of study drug.
  • History of hypersensitivity to theophylline or other xanthines and tigulixostat.

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Tigulixostat
Phase: 1
Study Start date:
October 31, 2023
Estimated Completion Date:
November 30, 2023

Connect with a study center

  • PPD - Austin Research Unit

    Austin, Texas 78744
    United States

    Site Not Available

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