The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers. This study will quantify drug and metabolites in blood, urine, and feces samples collected before study drug administration and through at least 168 hours after SC dosing of \[14C\]-RE104.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Single, subcutaneous dose of 2-\[14C\]-RE104 for Injection
PPD Inc.
Austin, Texas, United States
Total excreted radioactivity (Ae)
Time frame: Through 168 hours postdose
Cumulative recovery of total excreted radioactivity (CUM Ae)
Time frame: Through 168 hours postdose
Area under the concentration-time curve (AUC) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Time to reach Cmax (Tmax) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Terminal half-life (t1/2) of RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Apparent terminal elimination half-life (λz) for RE104 and 4-OH-DiPT
Time frame: Through 168 hours postdose
Mean residence time (MRT)
Time frame: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104
Time frame: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104
Time frame: Through 168 hours postdose
Total metabolite profiling with description of relevant PK parameters and structural identification of major metabolites present in all matrices
Time frame: Through 168 hours postdose
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Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness
A treatment-emergent adverse event (TEAE) is defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a study drug.
Time frame: From dosing (Day 0) through study completion (Day 7)