Status:
COMPLETED
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
Lead Sponsor:
LG Chem
Conditions:
Gout
Hyperuricemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06189404
Start Date
October 31 2023
End Date
November 30 2023
Last Update
January 3 2024
Active Locations (1)
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1
PPD - Austin Research Unit
Austin, Texas, United States, 78744