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GW642444H

Phase 1

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

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

GW642444H is an investigational small molecule being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered via inhalation and is currently in Phase 1 clinical development. The drug is not yet approved and remains under investigation for respiratory conditions.

Who makes GW642444H?

GW642444H 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 safety and efficacy of this investigational drug for respiratory diseases.

What phase is GW642444H in?

GW642444H is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is GW642444H in?

GW642444H has one completed Phase 1 clinical trial registered under NCT00463697. This study investigated the effect of inhaling a single dose of GW642444M in asthmatic patients. The trial enrolled 20 participants in the United Kingdom and was a randomized, double-blind, placebo-controlled study.

Is GW642444H the same as GW642444M?

GW642444H and GW642444M are related forms of the same investigational drug. The clinical trial NCT00463697 studied GW642444M, which is the active form administered via inhalation. GW642444H is the drug name used in development records, and both refer to the same compound under investigation.