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GSK615915A

Phase 1

Bronchospasm | Small molecule | Respiratory |GSK plc|Last Updated: Sep 29, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

GSK615915A · 1 trial · 1 indication

Phase 1 1
NCT00400660A First Time In Human Study To Assess The Compound GSK615915Bronchospasm
COMPLETED46 Analytics
PHASE1COMPLETED
A First Time In Human Study To Assess The Compound GSK615915
BronchospasmUnlock trial analytics

Study Endpoints

Primary Endpoints

Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG)
Up to 18 weeks

Secondary Endpoints

Levels of GSK615915A and any breakdown products in the blood and urine.
Up to 18 weeks
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Study Design & Arms

AllocationRANDOMIZED
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving treatment sequence 1: Part 1EXPERIMENTALEligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Subjects receiving treatment sequence 2: Part 1EXPERIMENTALEligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Subjects receiving treatment sequence 1: Part 2EXPERIMENTALEligible subjects will receive placebo followed by GSK615915A with a starting dose of 250 micrograms.
Subjects receiving treatment sequence 2: Part 2EXPERIMENTALEligible subjects will receive GSK615915A with a starting dose of 250 micrograms followed by placebo.
Subjects receiving GSK615915A: Part 3EXPERIMENTALEligible subjects will receive GSK615915A with a starting dose of 250 micrograms.
Subjects receiving placebo: Part 3EXPERIMENTALEligible subjects will receive placebo.

Interventions

NameTypeDescription
GSK615915ADRUGGSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
PlaceboDRUGSubjects will also receive placebo inhaler.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Women of non-child bearing potential. * Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m² * The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history ...

Countries:United Kingdom
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Frequently asked questions about GSK615915A

What is GSK615915A used for?

GSK615915A is an investigational small molecule being developed for bronchospasm, a condition involving the narrowing of airways in the lungs. It is currently in Phase 1 clinical development, meaning it is still being tested in early-stage human trials and has not yet been approved for any use.

Who makes GSK615915A?

GSK615915A is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK. The drug is an investigational small molecule intended for the treatment of bronchospasm.

What phase is GSK615915A in?

GSK615915A is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for bronchospasm, and its Phase 1 trial has been completed.

What clinical trials is GSK615915A in?

GSK615915A has been studied in one clinical trial, identified as NCT00400660, titled 'A First Time In Human Study To Assess The Compound GSK615915'. This Phase 1 trial was conducted in the United Kingdom and enrolled 46 participants, including healthy volunteers. The trial is now completed.

Is GSK615915A the same as GSK615915?

GSK615915A is the drug name used in the clinical trial record, while GSK615915 appears in the trial title. These names refer to the same investigational compound being developed by GSK plc for bronchospasm. The trial NCT00400660 studied this compound in healthy volunteers.