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GSK159802

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Trials Updated: Sep 29, 2017

GSK159802 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2006

GSK159802 target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

GSK159802 clinical trials

GSK159802 · 1 trial · 1 indication

Phase 1 1
NCT00364273GSK159802 In Healthy Male Subjects And AsthmaticsPulmonary Disease, Chronic Obstructive
COMPLETED43 Analytics
PHASE1COMPLETED
GSK159802 In Healthy Male Subjects And Asthmatics
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety & tolerability of single inhaled doses of GSK159802.
Up to 71 days

Secondary Endpoints

sGaw (Cohorts 1 and 2 only) and FEV1 Systemic & urine pharmacokinetics of GSK159802 and SKF-91300 Heart rate, potassium, glucose, 12-lead ECG & blood pressure
Up to 71 days
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Study Design & Arms

AllocationRANDOMIZED
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving treatment sequence 1 : Cohort 1EXPERIMENTALEligible subjects will receive placebo, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 2 : Cohort 1EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, placebo, GSK159802 600 micrograms, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 3 : Cohort 1EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, placebo, GSK159802 900 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 4 : Cohort 1EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, placebo and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 5 : Cohort 1EXPERIMENTALEligible subjects will receive GSK159802 150 micrograms, GSK159802 300 micrograms, GSK159802 600 micrograms, GSK159802 900 micrograms and placebo.
Subjects receiving treatment sequence 1 : Cohort 2EXPERIMENTALEligible subjects will receive placebo, salmeterol, GSK159802 low dose (LD) and GSK159802 maximum tolerated dose (MTD).
Subjects receiving treatment sequence 2 : Cohort 2EXPERIMENTALEligible subjects will receive salmeterol, GSK159802 MTD, placebo and GSK159802 LD.
Subjects receiving treatment sequence 3 : Cohort 2EXPERIMENTALEligible subjects will receive GSK159802 LD, placebo, GSK159802 MTD and salmeterol.
Subjects receiving treatment sequence 4 : Cohort 2EXPERIMENTALEligible subjects will receive GSK159802 MTD, GSK159802 LD, salmeterol and placebo.
Subjects receiving treatment sequence 1 : Cohort 3EXPERIMENTALEligible subjects will receive placebo, salmeterol, GSK159802 300 micrograms and GSK159802 1200 micrograms.
Subjects receiving treatment sequence 2 : Cohort 3EXPERIMENTALEligible subjects will receive salmeterol, GSK159802 1200 micrograms, placebo and GSK159802 300 micrograms.
Subjects receiving treatment sequence 3 : Cohort 3EXPERIMENTALEligible subjects will receive GSK159802 300 micrograms, placebo, GSK159802 1200 micrograms and salmeterol.
Subjects receiving treatment sequence 4 : Cohort 3EXPERIMENTALEligible subjects will receive GSK159802 1200 micrograms, GSK159802 300 micrograms, salmeterol and placebo.
Subjects receiving treatment sequence 5 : Cohort 3EXPERIMENTALEligible subjects will receive GSK159802 1200 micrograms, salmeterol, GSK159802 300 micrograms and placebo.

Interventions

NameTypeDescription
GSK159802DRUGGSK159802 will be available with dosing strengths of 75 microgram per blister and 300 microgram per blister administered using DISKUS inhaler.
PlaceboDRUGSubjects will receive placebo administered using DISKUS inhaler.
SalmeterolDRUGSalmeterol will be available with dosing strength of 50 micrograms per blister administered using DISKUS inhaler.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion criteria: * Body mass index within the range 18.5-29.9 (kg/m2) * Current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years. Additional criteria for Cohorts 2 and 3 only (Asthmatic Patients): ...

Countries:United Kingdom
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Frequently asked questions about GSK159802

What is GSK159802?

GSK159802 is an investigational small molecule developed by GSK plc for chronic obstructive pulmonary disease, a respiratory condition. It is a Phase 1 clinical candidate and has not been approved for any use. It was studied in a completed early-stage trial in healthy male volunteers and asthmatics.

What is GSK159802 used for in COPD?

GSK159802 is being developed for pulmonary disease, chronic obstructive pulmonary disease (COPD). It remains investigational and is not an approved COPD therapy. Its only recorded clinical study enrolled 43 participants and has completed, so no confirmed therapeutic use in COPD has been established.

What does GSK159802 target?

GSK159802 targets ADRB2, the beta-2 adrenergic receptor, and acts as an agonist at that receptor. ADRB2 agonism is the mechanism of bronchodilator drugs used in respiratory disease. GSK159802 is a small molecule agonist developed by GSK plc for chronic obstructive pulmonary disease.

Who makes GSK159802?

GSK159802 is made and developed by GSK plc, which trades under the ticker GSK. The compound is an investigational small molecule in the company's respiratory pipeline, being studied for chronic obstructive pulmonary disease. GSK plc is the sole developer identified for this asset.

What phase is GSK159802 in?

GSK159802 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulator. One Phase 1 trial has been completed, with no active trials currently recorded for the program.

What clinical trials is GSK159802 in?

GSK159802 has been studied in one completed Phase 1 trial, NCT00364273, titled GSK159802 In Healthy Male Subjects And Asthmatics. It enrolled 43 male participants aged 18 years and older in the United Kingdom, was randomized and controlled, and included healthy volunteers.