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Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Repeat IV Doses

NCT01615796 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2017-05-09

No results posted yet for this study

Summary

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials.

Conditions

  • Infections, Respiratory Tract

Interventions

DRUG

Part A: GSK2140944 Drug single dose of 200mg, 600mg, 1200mg, 1800 mg, and dose to be determined

Subjects receive a single dose of GSK2140944

DRUG

Part B: GSK2140944 Repeat Drug dose of 400mg, 750mg, 1000 mg, and dose to be determined

Subjects will receive repeat doses of GSK2140944 BID/TID for up to 14 Days

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-06-04
Primary Completion
2014-02-21
Completion
2014-02-21

Countries

  • Australia

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 NCT01615796 on ClinicalTrials.gov