Infections, Bacterial Clinical Trial
Official title:
An Open Label, Non-Randomized, Single Dose, Two Period, Cross-Over, Mass Balance Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C -GSK1322322 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects
This is a phase 1, non-randomized, open label, single-dose, two-period, cross-over study.
This study will utilize 14C radiolabeled GSK1322322 to investigate the recovery, excretion,
and pharmacokinetics of GSK1322322 in 6 healthy adult male subjects through the sampling of
blood, urine, and feces.
Each subject will participate in the study for approximately 7 to 8 weeks i.e., 30 day
screening period, two dosing periods (approximately 8 days each) and a follow up visit.
The subjects will be admitted to the clinical unit on Day 1 of the first treatment period
and remain in the unit for up to approximately 16 days through the end of the second
treatment period.
On Day 1 of Period 1, each subject will receive 14C radiolabeled GSK1322322 as a single
therapeutic intravenous (IV) dose (1000 milligrams [mg]). When the total radioactivity is
<1% of the administered dose in all subjects, Period 2 dosing will begin (approximately 8
days after the IV dose). On Day 1 of Period 2, each subject will receive single therapeutic
oral solution dose (1200 mg). Blood, urine, bile and fecal samples will be collected during
both the periods. The subject may be discharged from the unit as early as Day 8 of Period 2.
Subjects will visit the study unit for the follow-up visit 7 to 10 days following discharge
from the unit.
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