Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06189404
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06189404
Study Brief:
Protocol Section:
NCT06189404