This study is a Phase 1, single-center, open-label, single-dose study to evaluate (1) the absorption, metabolism, and excretion patterns of a single dose of \[14C\] PA-824, and (2) the pharmacokinetics, safety, and tolerability of a single oral-suspension dose of unlabeled PA-824 in healthy adult male subjects. Unlabeled PA-824 and \[14C\]-PA-824 will be administered together in an oral-suspension formulation. Enrollment is planned for one dose group of 6 subjects. All 6 subjects will receive the same treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Covance Clinical Research Unit
Madison, Wisconsin, United States
Characterize the plasma pharmacokinetic variable area under the curve of a single oral-suspension dose of PA-824.
Characterize the plasma pharmacokinetics of a single oral-suspension dose of PA-824 in healthy adult male subjects by calculating the variable area under the curve \[AUC (0-t)\] from total PA-824 plasma concentrations.
Time frame: Days 0-12
Characterize the plasma pharmacokinetic variable maximum concentration of a single oral-suspension dose of PA-824.
Characterize the plasma pharmacokinetics of a single oral-suspension dose of PA-824 in healthy adult male subjects by calculating the variable maximum plasma concentration (Cmax) from total PA-824 plasma concentrations.
Time frame: Days 0-12
Characterize the plasma pharmacokinetic variable time to peak plasma concentration of a single oral-suspension dose of PA-824.
Characterize the plasma pharmacokinetics of a single oral-suspension dose of PA-824 in healthy adult male subjects by calculating the variable time to peak plasma concentration (Tmax) from total PA-824 plasma concentrations.
Time frame: Days 0-12
The frequency and severity of treatment related adverse events throughout the study.
In order to evaluate the safety and tolerability of a single oral-suspension dose of PA-824 in healthy adult male subjects
Time frame: Days 0 -12
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