drugset / Trial / NCT02000765

A Study to Investigate the Recovery, Excretion and Pharmacokinetics of [14C]-GSK2140944 Administered as a Single Intravenous and Single Oral Dose to Healthy Adult Male Subjects

NCT02000765

Phase 1 Completed 6 enrolled GlaxoSmithKline
Non-randomizedCrossoverOpen-labelTreatment

Summary

This is an open-label, non-randomized, two-period, cross-over, mass balance study that will evaluate the recovery, excretion, and pharmacokinetics of a single intravenous (IV) dose of \[14C\]-GSK2140944 (Period 1) and a single oral dose of \[14C\]-GSK2140944 ( Period 2) in 6 healthy male subjects. The results from this study will aid in the design of future clinical pharmacology studies such as the thorough corrected QT interval study, special population studies (renal, hepatic, critically ill patients), potential drug interaction studies, and will help to establish safe and efficacious intravenous and oral dosing regimens.

Timeline

Start
2013-11-08
Primary completion
2013-11-30
Completion
2013-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Gepotidacin Small molecule 1000 mg Intravenous
Subject Gepotidacin Small molecule 2000 mg Intravenous