Effect of Tigulixostat on the Pharmacokinetics of Theophylline

Gout Clinical Trial

Official title:

A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Oral Doses of Tigulixostat on the Pharmacokinetics of a Single Oral Dose of Theophylline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06189404
• Other study ID #: LG-GDCL013
• Status: Completed
• Phase: Phase 1
• Start date: October 31, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2023
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 30, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• Tigulixostat
300 mg oral dose
• Theophylline
400 mg oral dose

Locations

Country	Name	City	State
United States	PPD - Austin Research Unit	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-t of theophylline with and without tigulixostat		Up to 72 hours
Primary	AUC0-inf of theophylline with and without tigulixostat		Up to 72 hours
Primary	Cmax of theophylline with and without tigulixostat		Up to 72 hours
Secondary	Incidence of reported adverse events (AEs)		Up to Day 28
Secondary	AUC0-t of tigulixostat and metabolite GD-MET-1		Up to 24 hours
Secondary	Cmax of tigulixostat and metabolite GD-MET-1		Up to 24 hours