Effect of Tigulixostat on the Pharmacokinetics of Theophylline (NCT06189404) | Clinical Trial Compass
CompletedPhase 1
Effect of Tigulixostat on the Pharmacokinetics of Theophylline
United States24 participantsStarted 2023-10-31
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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.
What they're measuring
1
AUC0-t of theophylline with and without tigulixostat
Timeframe: Up to 72 hours
2
AUC0-inf of theophylline with and without tigulixostat
Timeframe: Up to 72 hours
3
Cmax of theophylline with and without tigulixostat