Recent Updates
Recently added Catalysts

GW642444M for 14 days

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Last Updated: Aug 4, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

GW642444M for 14 days · 1 trial · 1 indication

Phase 1 1
NCT00469040Safety, Blood Levels and Effects of GW642444Pulmonary Disease, Chronic Obstructive
COMPLETED36 Analytics
PHASE1COMPLETED
Safety, Blood Levels and Effects of GW642444
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

General safety and tolerability as measured by ECG, blood pressure, pulse rate and blood and urine tests. Repeated measures on Day 1, 7 and 14
Repeated measures on Day 1, 7 and 14

Secondary Endpoints

Effects of the medicine on the body as measured by potassium and glucose levels in the blood. Monitoring of the study medicine in the body by analysis of blood samples. Repeated measures on Day 1, 7 and 14
Repeated measures on Day 1, 7 and 14
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GW642444M 25mcgEXPERIMENTALIn Cohort 1 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 25 mcg.
GW642444M 50mcgEXPERIMENTALSubjects after randomization will receive two inhalations of 25 mcg GW642444M in Cohort 1.
GW642444M 100mcgEXPERIMENTALIn Cohort 2 if subjects meet the stopping criteria the dose of GW642444M will changed to one inhalation of 100 mcg.
GW642444M 200mcgEXPERIMENTALSubjects after randomization will receive two inhalations of 100 mcg GW642444M in Cohort 2.
GW642444M 400mcgEXPERIMENTALSubjects after randomization will receive two inhalations of 200 mcg GW642444M in Cohort 3.

Interventions

NameTypeDescription
GW642444M for 14 daysDRUGM salt
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * healthy males and females (of non-childbearing potential) aged 18-55 * body weight \>50kg with BMI 19-29.9 kg/m2 * normal ECG recording * non-smoker Exclusion criteria: * high blood pressure (above 140/90 mmHg) * pulse outside range 45 - 90 bpm * history of breathing problem...

Countries:United Kingdom
Unlock Eligibility Criteria

Frequently asked questions about GW642444M for 14 days

What is GW642444M used for?

GW642444M is an investigational small molecule being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is in Phase 1 clinical development, with one completed trial evaluating its safety, blood levels, and effects in healthy volunteers.

Who makes GW642444M?

GW642444M is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company conducted a Phase 1 clinical trial of the drug in the United Kingdom.

What phase is GW642444M in?

GW642444M is in Phase 1 clinical development. The drug is investigational and not yet approved. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.

What clinical trials is GW642444M in?

GW642444M has one completed clinical trial, registered under NCT00469040, titled "Safety, Blood Levels and Effects of GW642444." This Phase 1 study enrolled 36 participants in the United Kingdom, including healthy volunteers aged 18 years and older.

Is GW642444M the same as GW642444?

GW642444M is the drug name used in the clinical trial record, while the trial title refers to GW642444. These names appear to refer to the same investigational compound being studied for chronic obstructive pulmonary disease.