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GSK1004723

Phase 2

Allergic Rhinitis | Small molecule | Respiratory |GSK plc|Trials Updated: Aug 10, 2017

GSK1004723 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jun 2008

GSK1004723 target and mechanism

Molecular targetHRH3, HRH1
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment73

FDA Designations

No designations recorded

GSK1004723 clinical trials

GSK1004723 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00824356Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With PlaceboAllergic Rhinitis
COMPLETED54 Analytics
PHASE2COMPLETED
Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in total nasal symptom score 0-4 hours post dose
0-4 hours post dose
ECG monitoring during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts.
during 24 hours after each dose in the single dose cohorts and on days 1 and 7 in the repeat dose cohorts
Heart rate and blood pressure changes over 24 hours after dosing in single and repeat dose cohorts
over 24 hours after dosing

Secondary Endpoints

Blood drug levels for GSK1004723 following single and repeat intranasal dosing
Pre-dose, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GSK1004726 (1000mg)ACTIVE_COMPARATOR1000mg aqueous suspension
PlaceboPLACEBO_COMPARATORIntranasal spray
GSK1004723 (200mg)ACTIVE_COMPARATOR200 mg aqueous suspension
Subjects receiving GSK1004723 + placebo in cohort I and IIEXPERIMENTALEligible subjects will receive GSK1004723 nasal spray with single doses of 50 micrograms, 100 micrograms, 200 micrograms, 500 micrograms and 1000 micrograms. Subjects will also receive placebo nasal spray.
Subjects receiving GSK1004723 200 micrograms in cohort IIIEXPERIMENTALEligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 200 micrograms given once daily for 14 days.
Subjects receiving placebo in cohort IIIEXPERIMENTALEligible subjects will receive nasal spray of placebo given once daily for 14 days.
Subjects receiving GSK1004723 1000 micrograms in cohort IVEXPERIMENTALEligible subjects will receive nasal spray of GSK1004723 with escalated repeat doses of 1000 micrograms given once daily for 14 days.
Subjects receiving placebo in cohort IVEXPERIMENTALEligible subjects will receive nasal spray of placebo given once daily for 14 days.

Interventions

NameTypeDescription
GSK1004723 (200mg)DRUGIntranasal antihistamine.
PlaceboOTHEREquivalent to GSK1004723 in presentation etc.
GSK1004723 (1000mg)DRUGIntranasal antihistamine.
GSK1004723DRUGGSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. * Male * Aged 18 - 65 * Weight 50kg+, BMI 19-32 kg/m2 * Exhibit response to Challenge Chamber and skin prick test. * Non-smoker * Capable of giving informed consent E...

Countries:Germany
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Competitive Landscape -Allergic Rhinitis 8 trials

Top 1 of 3 competitors

CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY1PHASE3LY3650150
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Frequently asked questions about GSK1004723

What is GSK1004723?

GSK1004723 is an investigational small molecule developed by GSK plc for allergic rhinitis and seasonal allergic rhinitis. It is an intranasal antagonist that targets both the HRH3 and HRH1 histamine receptors. It has been studied in Phase 1 and Phase 2 clinical trials and is not an approved product.

What is GSK1004723 used for?

GSK1004723 is being studied for the treatment of allergic rhinitis, including seasonal allergic rhinitis. Clinical testing has focused on nasal allergen challenge models in adults, where the drug is given intranasally as a single dose to assess its effects on allergy symptoms.

What does GSK1004723 target?

GSK1004723 targets the HRH3 and HRH1 histamine receptors and acts as an antagonist at both. This dual H1 and H3 antagonism is the basis for its development as an intranasal treatment for allergic rhinitis, aiming to block histamine-driven nasal allergic responses.

Who makes GSK1004723?

GSK1004723 is developed by GSK plc, which trades under the ticker GSK. The compound, identified by the ChEMBL ID CHEMBL1767164, is part of the company's respiratory research portfolio and has been evaluated in company-sponsored clinical studies.

What phase is GSK1004723 in?

GSK1004723 has completed Phase 2 development. A Phase 2 allergen challenge chamber study in allergic rhinitis was completed, and an earlier Phase 1 first-time-in-human study was also completed. There are no active trials of GSK1004723, and it is not an approved medicine.

What clinical trials is GSK1004723 in?

GSK1004723 has been studied in two completed trials. NCT00824356 was a Phase 2, randomized, double-blind, placebo-controlled allergen challenge chamber study of single-dose intranasal GSK1004723 in 54 men in Germany. NCT00694993 was a Phase 1 single and repeat dose first-time-in-human study in 19 healthy men.