A Single Oral Escalating Dose Study of GSK2140944 in Healthy Volunteers

Status Completed

Clinical Trial 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 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. This is a First Time in Human (FTIH) study to assess the safety, tolerability, and pharmacokinetics of single oral doses of GSK2140944 in healthy volunteers. This study will be a single-blind, randomized, placebo-controlled, dose-rising study in healthy subjects. The proposed single doses will range from 100 mg to 3000 mg.

Clinical Trial Description

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics which is being developed for treatment of Gram positive [including methicillin resistant Staphylococcus aureus (MRSA)] and Gram-negative pathogens associated with respiratory tract and skin and soft tissue infections including isolates resistant to existing classes of antimicrobials.

Study BTZ114595 will be the first administration of GSK2140944 in humans. This study will examine the safety, tolerability, and pharmacokinetics of escalating single oral doses of GSK2140944. The predicted clinical target for efficacy, based on preclinical efficacy models, is an AUC(0-24) of 16-30 μg.h/mL. This study aims to explore the safety and tolerability at and above target exposures in order to establish a therapeutic window for this compound.

This study will investigate the safety, tolerability, and pharmacokinetics of escalating single oral doses of GSK2140944.

This will be a randomized, placebo-controlled, single-blind study to determine safety, tolerability, and single dose pharmacokinetic (PK) profile of GSK2140944 in healthy subjects.

The projected single escalating doses of GSK2140944 will range from a starting dose of 100 mg to a maximum dose of 3000 mg. The current plan is to administer the study drug after an overnight fast, but based on emerging PK and safety data, it may be necessary to administer the study drug under fed state to better understand safety, tolerability or PK of GSK2140944. Any decision to remove or modify fasting requirements will be made by the GSK Study Team and the investigator based on joint review of the emerging safety, tolerability and preliminary pharmacokinetic data from prior dose-levels. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02202187
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 1
Start date	September 26, 2011
Completion date	February 15, 2012

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.