Phase 1, open-label, absorption, metabolism, excretion, and mass balance study.
A study of RPT193 in healthy volunteers to evaluate the route(s) of elimination and overall mass balance of RPT193 in urine and feces
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
7
Radiolabelled RPT193
Celerion
Lincoln, Nebraska, United States
Route(s) of elimination 1
Amount (in mass equivalents of parent drug) of radioactive drug excreted as TRA in urine and feces
Time frame: 14 days
Route(s) of elimination 2
Percent (%) of radioactive drug excreted as TRA in urine and feces
Time frame: 14 days
Quantitate total radioactivity (TRA)
Percent (%) of each drug-related material (parent and each metabolite) in whole blood, plasma, urine and feces
Time frame: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of area under the curve (AUC) in plasma and urine
Time frame: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of peak plasma concentration (Cmax) in plasma and urine
Time frame: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of time to peak plasma concentration (Tmax) in plasma and urine
Time frame: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of half-life in plasma and urine
Time frame: 14 days
Characterize pharmacokinetics (PK) profile of RPT193
Calculation of elimination constant in plasma and urine
Time frame: 14 days
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