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GW597901X

Phase 1

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: May 18, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

GW597901X · 1 trial · 1 indication

Phase 1 1
NCT00354042Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic SubjectsAsthma
COMPLETED24 Analytics
PHASE1COMPLETED
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
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Study Endpoints

Primary Endpoints

Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.

Secondary Endpoints

Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
GW597901XDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo

Inclusion criteria: * Subjects with mild to moderate stable asthma but no other lung problems. * Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile). * Non-Smokers. * Subjects who show a measurable improvement in the function of their lungs...

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Frequently asked questions about GW597901X

What is GW597901X used for?

GW597901X is an investigational small molecule being developed for the treatment of asthma. It is administered via inhalation and is intended to affect lung function in asthmatic patients. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes GW597901X?

GW597901X is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the safety and effects of this investigational drug in patients with asthma.

What phase is GW597901X in?

GW597901X is in Phase 1 clinical development. A Phase 1 trial has been completed to assess the safety and lung function effects of repeat inhaled doses in asthmatic subjects. The drug remains investigational and has not received approval for commercial use.

What clinical trials is GW597901X in?

GW597901X has one completed clinical trial registered under NCT00354042, titled 'Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects.' This Phase 1 study enrolled 24 participants with asthma and was completed, with no active trials currently ongoing.

Is GW597901X FDA approved?

GW597901X is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for asthma. The completed Phase 1 trial focused on safety and lung function, but the drug has not yet progressed to later-stage trials or received regulatory approval.