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GW685698X & GW642444M

Phase 1

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Aug 4, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

GW685698X & GW642444M · 1 trial · 1 indication

Phase 1 1
NCT00538057Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy SubjectsAsthma
COMPLETED16 Analytics
PHASE1COMPLETED
Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum heart rate
over 4 hours after dosing.
Blood pressure
changes over 12 hours.
Electrocardiogram
changes over 12 hours.
Change in peak expiry flow rate
changes over 24 hours.
Change in serum cortisol concentration
changes over 24 hours.

Secondary Endpoints

Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
over 48 hours after dosing.
Change in blood potassium levels
within 4 hours of drug dosing.
Mean heart rate
over 4 hours after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
arm 1EXPERIMENTALstudy drug

Interventions

NameTypeDescription
GW685698X & GW642444MDRUGstudy drug
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Healthy adults aged between 18 and 60 years. * Male subjects or female subjects of non child bearing potential. * Body weight at least 50 kg and BMI within the range of 19-31 kg/m2 inclusive. * No significant abnormality from ECG at screening. * FEV1 at least 90% predicted and...

Countries:Australia
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Frequently asked questions about GW685698X & GW642444M

What is GW685698X & GW642444M used for?

GW685698X & GW642444M is an investigational small molecule combination being developed for asthma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The combination is being studied for its potential use in treating asthma, though it remains in early-stage clinical trials.

Who makes GW685698X & GW642444M?

GW685698X & GW642444M is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical research on this combination therapy for asthma, with the drug currently in Phase 1 development.

What phase is GW685698X & GW642444M in?

GW685698X & GW642444M is in Phase 1 clinical development. It is an investigational drug and has not been approved for use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical testing for asthma.

What clinical trials is GW685698X & GW642444M in?

GW685698X & GW642444M has one completed clinical trial, registered as NCT00538057. This Phase 1 study compared the two respiratory drugs when used in combination and separately from a novel inhaler device in healthy subjects. The trial enrolled 16 participants in Australia and was completed.

Is GW685698X & GW642444M the same as GW685698X and GW642444M?

GW685698X & GW642444M is a combination of two drugs, GW685698X and GW642444M, studied together as a single investigational therapy. The clinical trial NCT00538057 compared the combination against each drug used separately, all administered from a novel inhaler device.