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GSK159802

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

GSK159802 is an investigational small molecule being developed for chronic obstructive pulmonary disease (COPD). It is a respiratory therapeutic that has been studied in a Phase 1 clinical trial. The drug is not approved and remains in early clinical development.

Who makes GSK159802?

GSK159802 is being developed by GSK plc, a pharmaceutical company traded 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 GSK159802 in?

GSK159802 is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a controlled study in healthy male subjects and asthmatics. The drug is investigational and has not been approved for any use.

What clinical trials is GSK159802 in?

GSK159802 has one completed clinical trial, identified as NCT00364273. This Phase 1 study enrolled 43 participants in the United Kingdom and evaluated the drug in healthy male subjects and asthmatics with chronic obstructive pulmonary disease.

How does GSK159802 work?

GSK159802 is a small molecule therapeutic developed for respiratory conditions. Its specific molecular target has not been disclosed in available information, so the exact mechanism of action is not publicly detailed.