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GW642444H

Phase 2

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Trials Updated: Aug 7, 2017

GW642444H development status

Highest phase Phase 2 (NCT00519376)
Phase scored for GSKPhase 1
Registered trials 2 across 1 sponsor since Sep 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

GW642444H clinical trials

GW642444H · 1 trial · 1 indication

Phase 1 1
NCT00463697A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic PatientsPulmonary Disease, Chronic Obstructive
COMPLETED20 Analytics
PHASE1COMPLETED
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In Asthmatic Patients
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

General safety and tolerability of the new formulation of GW642444 as measured by ECG, blood pressure, pulse rate and blood and urine tests. Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).
Serial measurements are made over 24 hours on 5 separate occasions (separated by 1 - 2 weeks).

Secondary Endpoints

Airways relaxation assessed by lung function tests. Effect of study medicine on the body and amount of medicine in the body measured by potassium, glucose and medicine in blood samples. Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
Measurements made over 24 hours on 5 occasions (1-2 weeks apart).
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GW642444M 25mcgEXPERIMENTALSubject will inhale single dose of GW642444M 25 mcg via a DISKUS device in morning.
GW642444M 100mcgEXPERIMENTALSubject will inhale single dose of GW642444M 100 mcg via a DISKUS device in morning.
GW642444M 400mcgEXPERIMENTALSubject will inhale single dose of GW642444M 400 mcg via a DISKUS device in morning.
GW642444H 100mcgEXPERIMENTALSubject will inhale single dose of GW642444H 100 mcg via a DISKUS device in morning.
placeboPLACEBO_COMPARATORSubject will inhale single dose of Placebo via a DISKUS device in morning.

Interventions

NameTypeDescription
GW642444H (100mcg)DRUGH salt
placeboDRUGplacebo
GW642444M (25, 100 & 400 mcg)DRUGM salt
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: * male or female (of non-childbearing potential) between 18 - 70 years * History of stable mild to moderate asthma * non - smokers * currently taking daily doses of inhaled fluticasone propionate 200 - 500 mcg (or equivalent) * body weight \>50 kg with BMI 19-29.9 kg/m2 * normal...

Countries:United Kingdom
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Frequently asked questions about GW642444H

What is GW642444H?

GW642444H is an investigational small molecule drug developed by GSK plc for Pulmonary Disease, Chronic Obstructive, a respiratory condition. It has been studied in a single Phase 1 clinical trial and is not approved for any use. The compound is also referred to as GW642444H (100mcg), reflecting the 100 microgram dose evaluated in testing.

What is GW642444H used for in COPD?

GW642444H has been studied for Pulmonary Disease, Chronic Obstructive, commonly known as COPD. The only registered trial involving this drug was conducted in patients with that condition. It remains an investigational agent and is not approved for the treatment of COPD or any other indication.

Who makes GW642444H?

GW642444H is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1 study of the compound. No other developer or partner is associated with this asset based on the available information.

What phase is GW642444H in?

GW642444H is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is GW642444H in?

GW642444H has been evaluated in one completed Phase 1 trial, NCT00463697, titled a study to investigate the effect of inhaling a single dose of GW642444M in asthmatic patients. The trial enrolled 20 participants in the United Kingdom and was randomized, double-blind, and placebo-controlled.