This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive \[14C\] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg containing approximately 100 μCi of \[14C\] baxdrostat. Subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
a blood pressure lowering drug, oral dose
Labcorp Clinical Research Unit
Madison, Wisconsin, United States
Total radioactivity recovery in urine and feces following administration of [14C] baxdrostat.
Measurement of total radioactivity recovery in urine and feces to determine the routes, rates of elimination, and mass balance of total radioactivity from \[14C\] baxdrostat.
Time frame: 1 to 15 days after dosing
Area under the curve [AUC] of baxdrostat and its primary metabolite (CIN-107M) following administration of [14C] baxdrostat to healthy male subjects.
Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and CIN-107M in plasma.
Time frame: 1 to 15 days after dosing
Cumulative baxdrostat and CIN-107M excreted in urine and fraction of baxdrostat renally excreted following administration of [14C] baxdrostat to healthy subjects.
Determining cumulative amount of baxdrostat and CIN-107M excreted in urine, clearance of baxdrostat and CIN-107M, and fraction of dose excreted renally (baxdrostat only).
Time frame: 1 to 15 days after dosing
Maximum concentration [Cmax] for baxdrostat and CIN-107M in plasma.
Cmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Time frame: 1 to 15 days after dosing
Time to maximum concentration [Tmax] for baxdrostat and CIN-107M in plasma.
Tmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Time frame: 1 to 15 days after dosing
Terminal elimination half-life (t1/2) for baxdrostat and CIN-107M in plasma.
t1/2 for baxdrostat and CIN-107M in plasma will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Time frame: 1 to 15 days after dosing
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Quantitative metabolic profiles of baxdrostat in plasma and excreta.
To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after \[14C\]-baxdrostat
Time frame: 1 to 15 days after dosing
Identification of baxdrostat metabolites in plasma and excreta.
To determine, where possible, the chemical structure of major metabolites in plasma, urine, and feces after \[14C\]-baxdrostat
Time frame: 1 to 15 days after dosing
Incidence of treatment emergent adverse events following administration of [14C] baxdrostat.
Incidence of adverse events will be used to assess the safety and tolerability of \[14C\] baxdrostat when administered to healthy subjects.
Time frame: 1 to 15 days after dosing