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GSK1004723

Phase 1

Rhinitis, Allergic, Seasonal | Small molecule | Other |GSK plc|Last Updated: Aug 10, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00694993Single and Repeat Dose First Time in Human Study for an Intranasal H1/H3 Dual Antagonist in Healthy Male SubjectsPHASE1 COMPLETED 19 — — Dec 17, 2007May 26, 2008Aug 10, 20171 Germany
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Study Endpoints
Primary Endpoints
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
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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
GSK1004723DRUGGSK1004723 will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
PlaceboDRUGPlacebo will be supplied as intranasal sprays aqueous suspensions for intranasal spray administration.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male subjects aged between 18 and 50 years inclusive. * Body mass index within the range 19-29.9kg/m2 (inclusive), with weight range of 50 kg-100 kg (inclusive). * Healthy (defined as individuals who are free from significant nasal, cardiac, pulmonary, gastrointestinal, hepati...

Countries:Germany
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