The main purpose of this study is to conduct blood tests to measure how much STX-478 is in the bloodstream and how the body handles and eliminates it in healthy participants. This study will involve a single dose of 14C radiolabeled STX-478. This means that a radioactive tracer substance, C14, will be incorporated into the study drug STX-478 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of STX-478.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
oral administration
Pharmaron Clinical Pharmacology Center Inc
Baltimore, Maryland, United States
Percentage of the Total Radioactive Dose in Urinary, Fecal, and Urinary and Fecal Combined Excretion
Time frame: Baseline, Up to Day 29
Pharmacokinetics (PK): Maximum Concentration (Cmax) of 14C and STX-478
Time frame: Predose up to Day 29 Post Dose
PK: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC 0- inf) of 14C and STX-478
Time frame: Predose up to Day 29 Post Dose
Total Radioactivity Recovered in Urine and Feces
Time frame: Predose up to Day 29 Post Dose
Total Number of Metabolites and Identification of Metabolites of STX-478 in Plasma, Urine, and Feces
Time frame: Predose up to Day 29 Post Dose
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