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GSK704838

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Oct 31, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

GSK704838 · 1 trial · 1 indication

Phase 1 1
NCT00539825Effect of GSK704838 In Healthy VolunteersPulmonary Disease, Chronic Obstructive
COMPLETED20 Analytics
PHASE1COMPLETED
Effect of GSK704838 In Healthy Volunteers
Pulmonary Disease, Chronic Obstructive
NCT0053982520
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Study Endpoints

Primary Endpoints

adverse events, vital signs,12-lead ECG, Holter and ECG monitoring,lung function and clinical lab tests. These will be taken pre-dose and at multiple time points up to 48h at each treatment period.

Secondary Endpoints

- Plasma and urine concentrations of GSK704838 and derived pharmacokinetic parameters over 48h post-dose. - Serial sGaw, Raw and FEV1 measurements over 24h post-dose.
Serial specific airway conductance (sGaw), Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity measurements (FVC) over 24 hours post-dose of GSK704838 and tiotropium bromide.
Serial sGaw measurements over 48 hours for the last period in each cohort dose of GSK704838 and tiotropium bromide.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
GSK704838DRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male subject * Aged between 18-55 years inclusive. * Non-smokers * Normal spirometry * A signed and dated written informed consent is obtained from the subject. * The subject is capable of giving informed consent, which includes compliance with the requirements and res...

Countries:United Kingdom
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Frequently asked questions about GSK704838

What is GSK704838 used for?

GSK704838 is an investigational small molecule being developed for Chronic Obstructive Pulmonary Disease (COPD), a type of pulmonary disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved and is still being studied for safety and tolerability in early-stage trials.

Who makes GSK704838?

GSK704838 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's effects in healthy volunteers as part of its early-stage research program.

What phase is GSK704838 in?

GSK704838 is in Phase 1 clinical development. This is the earliest stage of human testing, focused on assessing the drug's safety, tolerability, and how it behaves in the body. It is investigational and has not been approved for any use.

What clinical trials is GSK704838 in?

GSK704838 has one completed Phase 1 trial, registered as NCT00539825, titled 'Effect of GSK704838 In Healthy Volunteers.' The study enrolled 20 healthy male participants in the United Kingdom and was designed to evaluate the drug's effects in a controlled setting.

Is GSK704838 the same as any other drug?

No alternative names for GSK704838 have been disclosed. The drug is identified solely by its development code, GSK704838, and is not known to be marketed under any other brand name or alias.