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GW328267X

Phase 1

Lung Injury, Acute | Small molecule | Respiratory |GSK plc|Last Updated: Jun 12, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment3

FDA Designations

No designations recorded

Clinical trial landscape

GW328267X · 1 trial · 1 indication

Phase 1 1
NCT01640990A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy VolunteersLung Injury, Acute
COMPLETED3 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Intravenous Infusion of GW328267X in Healthy Volunteers
Lung Injury, Acute
NCT016409903
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Study Endpoints

Primary Endpoints

Safety and tolerability including number of subjects with adverse events assessment
baseline, Day 1, Day 2 and Day 10
Safety and tolerability including change from baseline and number subjects with abnormal clinical safety laboratory data
baseline, Day 1, Day 2 and Day 10
Safety and tolerability, including change from baseline and number of subjects with abnormal ECG assessments
baseline, Day 1, Day 2 and Day 10
Safety and tolerability, including change from baseline and number of subjects with abnormal vital signs (blood pressure and heart rate) assessments
baseline, Day 1, Day 2 and Day 10

Secondary Endpoints

Heart rate changes from baseline during intravenous infusion of GW328267X
baseline, Day 1, Day 2 and Day 10
Platelet aggregation parameters
Pre-dose, Day 1 5.5 hr, Day 2
Erythropoietin levels
Screening, Pre-dose, Day 2, Follow Up
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALslow IV infusion over 6 hours consisting of saline for 30 minutes (run in period), 8 mcg/h GW328267X for 1.5 hours (total dose of 12mcg), and 10 mcg/h GW328267X for 4 hours (total dose of 40 mcg)
Cohort 2EXPERIMENTALDose to be determined after analysis of Cohort 1

Interventions

NameTypeDescription
SalineDRUG30mins run-in period
GW328267X (total dose of 12mcg)DRUG8 mcg/h for 1.5 hours (total dose of 12mcg)
GW328267X (total dose of 40mcg)DRUG10 mcg/h for 4 hours (total dose of 40 mcg)
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range ...

Countries:United Kingdom
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Frequently asked questions about GW328267X

What is GW328267X used for?

GW328267X is an investigational small molecule being developed for acute lung injury. It is a respiratory therapeutic that has been studied in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes GW328267X?

GW328267X is being developed by GSK plc, which trades under the ticker GSK. The company conducted a Phase 1 study of the drug in healthy volunteers in the United Kingdom.

What phase is GW328267X in?

GW328267X is in Phase 1 clinical development. A single Phase 1 trial has been completed, and the drug is not approved. It remains investigational.

What clinical trials is GW328267X in?

GW328267X has one completed Phase 1 trial, NCT01640990, which assessed safety, tolerability, pharmacokinetics, and pharmacodynamics of an intravenous infusion in healthy volunteers. The trial enrolled 3 male participants in the United Kingdom.

Is GW328267X FDA approved?

GW328267X is not FDA approved. It is an investigational drug that has completed a Phase 1 trial. The drug is still in clinical development and has not been approved for any use.