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

NCT01610388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-06-12

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-13
Primary Completion
2012-01-26
Completion
2012-01-26

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01610388 on ClinicalTrials.gov