NCT01610388

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled Repeat Dose Escalation, First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This first time in human (FTIH) study will be the first administration of GSK1322322 as an intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma concentrations to evaluate drug penetration in the lung. The study will evaluate the absolute bioavailability of an oral tablet formulation as compared to the IV formulation.In addition, Amendment 01 will enable the investigation of an improved IV formulation (GSK1322322J mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic cohort.

Conditions

• Infections, Bacterial

Interventions

Type	Name	Description
DRUG	500mg IV GSK1322322/placebo	500mg IV
DRUG	1000mg oral GSK1322322/placebo	1000mg oral
DRUG	1000mg IV GSK1322322/placebo	1000mg IV
DRUG	1500mg oral GSK1322322/placebo dose	1500mg oral
DRUG	1500mg IV GSK1322322/placebo	1500mg IV
DRUG	2000mg IV GSK1322322J/placebo	2000mg IV
DRUG	3000mg IV GSK1322322J/placebo	3000mg IV
DRUG	1000mg IV GSK1322322J/placebo	1000mg IV

Timeline

• Start date: 2011-09-13
• Primary completion: 2012-01-26
• Completion: 2012-01-26
• First posted: 2012-06-04
• Last updated: 2017-06-12

Locations

1 site across 1 country: United States