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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
300 mg oral dose
400 mg oral dose
PPD - Austin Research Unit
Austin, Texas, United States
AUC0-t of theophylline with and without tigulixostat
Time frame: Up to 72 hours
AUC0-inf of theophylline with and without tigulixostat
Time frame: Up to 72 hours
Cmax of theophylline with and without tigulixostat
Time frame: Up to 72 hours
Incidence of reported adverse events (AEs)
Time frame: Up to Day 28
AUC0-t of tigulixostat and metabolite GD-MET-1
Time frame: Up to 24 hours
Cmax of tigulixostat and metabolite GD-MET-1
Time frame: Up to 24 hours
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