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GSK945237

Phase 1

Infections, Bacterial | Small molecule | Infectious Disease |GSK plc|Trials Updated: Mar 19, 2012

GSK945237 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Aug 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

GSK945237 clinical trials

GSK945237 · 1 trial · 2 indications

Phase 1 1
NCT00517673To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy SubjectsHealthy Subjects
COMPLETED68 Analytics
PHASE1COMPLETED
To Evaluate Safety, Tolerability, Pharmacokinetics, And Food Effect Of Single Doses Of GSK945237 In Healthy Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability
Day 1 to follow-up visit

Secondary Endpoints

Pharmacokinetics
Day 1 to Day 5
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
GSK945237EXPERIMENTALActive Study Drug
Sugar PillPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
GSK945237DRUG -
Sugar PillDRUGPlacebo
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female adults between 18 and 60 years of age. * Body weight proportional to height. * Female subjects must be of non-childbearing potential. * QTc less than 450 msec at screening Exclusion Criteria: * Any clinically relevant abnormality identified on the scr...

Countries:Australia
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Frequently asked questions about GSK945237

What is GSK945237?

GSK945237 is an investigational small molecule antibacterial being developed by GSK plc for bacterial infections. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. It is not an approved medicine and remains in early clinical development.

What is GSK945237 used for?

GSK945237 is being developed for bacterial infections. The only recorded human study of GSK945237 enrolled healthy volunteers rather than patients, so it was designed to assess safety, tolerability and pharmacokinetics rather than to treat an active infection. Its use in patients has not been established.

Who makes GSK945237?

GSK945237 is developed by GSK plc, which trades under the ticker GSK. The compound is an internally originated small molecule antibacterial candidate in the company's infectious disease pipeline.

What phase is GSK945237 in?

GSK945237 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. As an investigational agent, GSK945237 has not been approved by the FDA or any other regulator for any indication.

What clinical trials has GSK945237 been studied in?

GSK945237 has been evaluated in one completed Phase 1 trial, NCT00517673, titled a study to evaluate safety, tolerability, pharmacokinetics and food effect of single doses of GSK945237 in healthy subjects. It was a randomized, placebo-controlled trial that enrolled 68 healthy adults in Australia.

Was the GSK945237 trial in healthy volunteers?

Yes. The completed Phase 1 trial NCT00517673 enrolled 68 healthy adult volunteers aged 18 years and older in Australia. It was randomized and placebo-controlled but not double-blind, and it assessed single doses of GSK945237 for safety, tolerability, pharmacokinetics and food effect.