Gout, Hyperuricemia
Conditions
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.
Interventions
DRUGTigulixostat
300 mg oral dose
DRUGTheophylline
400 mg oral dose
Sponsors
LG Chem
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-t of theophylline with and without tigulixostat | Up to 72 hours |
| AUC0-inf of theophylline with and without tigulixostat | Up to 72 hours |
| Cmax of theophylline with and without tigulixostat | Up to 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of reported adverse events (AEs) | Up to Day 28 |
| AUC0-t of tigulixostat and metabolite GD-MET-1 | Up to 24 hours |
| Cmax of tigulixostat and metabolite GD-MET-1 | Up to 24 hours |
Countries
United States
Outcome results
None listed