The purpose of this study is to determine the absorption, metabolism, and excretion of \[14C\]-TBPM-PI-HBr and to characterize and determine the metabolites present in plasma, urine, and where possible, feces in healthy male subjects following a single oral administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
TBPM-PI-HBr (3 x 200 mg tablets) once
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, United States
Pharmacokinetics (PK) of Tebipenem (TBPM) will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects
The primary PK outcome endpoints following oral administration of \[14C\]-TBPM-PI-HBr will be derived for TBPM in plasma (calculated from whole blood concentrations) based on the concentration-time profile
Time frame: Day 1 to Day 5
Total radioactivity will be determined following administration of [14C]-TBPM-PI-HBr to healthy male subjects
The primary PK outcome endpoints following oral administration of \[14C\]-TBPM-PI-HBr will be derived for total radioactivity in whole blood and plasma based on the total radioactivity concentration-time profile
Time frame: Day 1 to Day 5
Metabolite profiling and chemical structuring of metabolites in plasma, urine, and, where possible, feces will be determined after a single oral dose of [14C]-TBPM-PI-HBr
The secondary metabolite outcome endpoints will be derived: * metabolic profile of TBPM-PI-HBr * metabolic profile of TBPM-PI-HBr
Time frame: Day 1 to Day 5
Metabolite profiling and chemical structuring of metabolites in plasma, urine, and, where possible, feces will be determined after a single oral dose of [14C]-TBPM-PI-HBr
The secondary metabolite outcome endpoints will be derived: • identification of the structure of TBPM-PI-HBr metabolites
Time frame: Day 1 to Day 5
The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.
The secondary safety outcome measures for this study are as follows: • incidence and severity of AEs
Time frame: Day 1 to Day 5
The safety and tolerability of a single oral dose of [14C]-TBPM-PI-HBr when administered to healthy male subjects.
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The secondary safety outcome measures for this study are as follows: •incidence of laboratory abnormalities, based on hematology, clinical chemistry, coagulation, and urinalysis test results
Time frame: Day 1 to Day 5