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
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 StatesSite Not Available
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