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GSK233705

Phase 2

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |GSK plc|Last Updated: Sep 1, 2020

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials9
Total Enrollment794
FDA Designations
No designations recorded
Clinical Trials (9)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00749411Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPDPHASE2 COMPLETED 61 — — Nov 13, 2008Feb 12, 2009Sep 1, 202012 United States
NCT00676052Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)PHASE2 COMPLETED 576 — — May 16, 2008Dec 22, 2008Oct 9, 201788 United States, Argentina +12
NCT00376714Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary DiseasePHASE2 COMPLETED 45 — — Aug 16, 2006Apr 3, 2007Jun 7, 20185 Belgium, Sweden
NCT00783003A Study to Assess the Safety and Pharmacokinetics of Inhaled Doses of GSK233705 and GW642444 in Healthy SubjectsPHASE1 COMPLETED 16 — — Nov 10, 2008Feb 6, 2009Jul 18, 20171 United Kingdom
NCT00964405Phase I Study of GSK233705 in Healthy Japanese Male SubjectsPHASE1 COMPLETED 28 — — Sep 20, 2008Dec 20, 2008Aug 3, 20171 Japan
NCT00671216A Study to Assess the Safety and Pharmacokinetics of Inhaled Doses of GSK233705 and GW642444 in Healthy Subjects.PHASE1 COMPLETED 16 — — May 20, 2008Jul 7, 2008Oct 4, 20171 United Kingdom
NCT00500461Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705PHASE1 COMPLETED 9 — — Jun 4, 2007Jul 25, 2007Aug 7, 20171 United Kingdom
NCT00453687A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK233705 In Healthy Volunteers.PHASE1 COMPLETED 12 — — Mar 9, 2007May 16, 2007Aug 7, 20171 United States
NCT00279019Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary DiseasePHASE1 COMPLETED 31 — — Dec 12, 2005Jun 13, 2006Sep 25, 20173 Germany
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Study Endpoints
Primary Endpoints
Change From Baseline in Weighted Mean Pulse Rate Over (0-4 Hours) at Day 28.
Baseline (Pre-dose, Day 1) and Day 28

Baseline was the most recent result taken on or before pre-dose (Day 1). The analysis was performed using a Repeated Measures Model. This model used all available weighted mean pulse rate values recorded. Change from Baseline was calculated as (Change from Baseline = Assessment value - Baseline value).

Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 29
Baseline (pre-dose Day 1) and Day 29

The trough FEV1 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Day 28. The Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose \[time 0\] on Day 1. Change from Baseline was calculated by subtracting the post-baseline assessment value from the Baseline value.

Adverse events Blood pressure Heart rate 12-lead ECG Holter monitoring Lead II ECG monitoring Lung function Clinical laboratory safety tests.
Heart rate
24 hours
Systolic and diastolic blood pressure
24 hours
12 lead ECG
24 hours
Lung Function
24 hours
Clinical laboratory safety tests
24 hours
Adverse events
Duration of study
Safety：adverse events, vital sign, ECGs, and clinical laboratory test
PK：Cmax, tmax and AUC(0-t)
General safety endpoints: measured over 24 hours post dose for all 4 dose periods, heart rate, systolic and diastolic blood pressure, 12- lead ECG and lung function and clinical laboratory safety tests. Adverse events over whole study.
Up to Day 2
Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,
out to 8 hours post dose
measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and
out to 24 hours
review of adverse events ongoing through out study.
through out study.
General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, lung function (FEV1, FVC) and clinical laboratory safety tests over 24 hours.
over 24 hours.
Adverse events, blood pressure, heart rate, 12-lead electrocardiogram (ECG), Holter and Lead II ECG monitoring, ECG, lung function and clinical laboratory safety tests.
Up to Week 12
Secondary Endpoints
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
On-treatment; from treatment start until one day after treatment stop (Up to Day 29)
Change From Baseline in Weighted Mean for 0 to 24 Hours Serial FEV1 on Day 1 to 2 and 28 to 29
Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
Change From Baseline in Weighted Mean for 0 to 24 Hours Forced Vital Capacity (FVC) on Day 1 to 2 and 28 to 29
Baseline (pre-dose Day 1) and Days 1 to 2, Days 28 to 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2PLACEBO_COMPARATOR -
Arm 3EXPERIMENTALGSK233705 50mcg
Arm 4EXPERIMENTALGSK233705 100mcg
Arm 5EXPERIMENTALGSK233705 200mcg
Arm 6PLACEBO_COMPARATORPlacebo
Long acting muscarinic receptor antagonist (LAMA)EXPERIMENTALInhaled Long acting muscarinic receptor antagonist (LAMA which is in development as a treatment for Chronic Obstructive Pulmonary Disease.
Long acting Beta 2 agonist (LABA)EXPERIMENTALInhaled Long Acting Beta 2 agonist (LABA) which is in development as a treatment for Chronic Obstructive Pulmonary Disease.
LAMA with LABAEXPERIMENTALInhaled Long Acting Muscarinic receptor Antagonist (LAMA) and a inhaled Long Acting Beta 2 Agonist (LABA), both in development for treatment of Chronic Obstructive Pulmonary Disease and taken in combination.
PlaceboPLACEBO_COMPARATORMatching placebo, no intervention.
LAMAEXPERIMENTALAfter randomization subject will inhale either GSK233705 50, 100 or 200 microgram once daily for 7 days.
Period 1EXPERIMENTALSubjects will receive first placebo, then GSK233705, GW642444 and combination of GSK233705 and GW642444
Period 2EXPERIMENTALSubjects will receive first combination of GSK233705 and GW642444, then placebo, GSK233705 and GW642444
Period 3EXPERIMENTALSubjects will receive first GSK233705, then GW642444, combination of GSK233705 and GW642444 and later placebo
Period 4EXPERIMENTALSubjects will receive first GW642444, then combination of GSK233705 and GW642444, placebo, and later GSK233705
Subjects receiving GSK233705EXPERIMENTALEach subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.
Subjects receiving treatment sequence 1EXPERIMENTALEligible subjects will receive treatment sequence 1; GSK233705 20 micrograms, GSK233705 100 micrograms, tiotropium and placebo.
Subjects receiving treatment sequence 2EXPERIMENTALEligible subjects will receive treatment sequence 2; GSK233705 20 micrograms, Placebo, GSK233705 50 micrograms and tiotropium.
Subjects receiving treatment sequence 3EXPERIMENTALEligible subjects will receive treatment sequence 3; GSK233705 20 micrograms, tiotropium, Placebo and GSK233705 50 micrograms.
Subjects receiving treatment sequence 4EXPERIMENTALEligible subjects will receive treatment sequence 4; GSK233705 20 micrograms, placebo, tiotropium and GSK233705 50 micrograms.
Subjects receiving treatment sequence 5EXPERIMENTALEligible subjects will receive treatment sequence 5; Placebo, tiotropium, GSK233705 20 micrograms and GSK233705 50 micrograms.
Subjects receiving treatment sequence 6EXPERIMENTALEligible subjects will receive treatment sequence 6; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and tiotropium.
Subjects receiving treatment sequence 7EXPERIMENTALEligible subjects will receive treatment sequence 7; tiotropium, GSK233705 20 micrograms, GSK233705 50 micrograms and Placebo.
Subjects receiving treatment sequence 8EXPERIMENTALEligible subjects will receive treatment sequence 8; tiotropium, GSK233705 20 micrograms, Placebo and GSK233705 50 micrograms.
Subjects receiving treatment sequence 9EXPERIMENTALEligible subjects will receive treatment sequence 9; GSK233705 20 micrograms, tiotropium, GSK233705 50 micrograms and Placebo.
Subjects receiving treatment sequence 10EXPERIMENTALEligible subjects will receive treatment sequence 10; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and tiotropium.
Subjects receiving treatment sequence 11EXPERIMENTALEligible subjects will receive treatment sequence 11; Placebo, GSK233705 20 micrograms, tiotropium, and GSK233705 50 micrograms.
Subjects receiving treatment sequence 12EXPERIMENTALEligible subjects will receive treatment sequence 12; Tiotropium, Placebo, GSK233705 20 micrograms and GSK233705 50 micrograms.
Subjects receiving treatment sequence 13EXPERIMENTALEligible subjects will receive treatment sequence 13; Placebo, GSK233705 20 micrograms, GSK233705 50 micrograms and GSK233705 100 micrograms.
Subjects receiving treatment sequence 14EXPERIMENTALEligible subjects will receive treatment sequence 14; GSK233705 20 micrograms, placebo, GSK233705 50 micrograms and GSK233705 100 micrograms.
Subjects receiving treatment sequence 15EXPERIMENTALEligible subjects will receive treatment sequence 15; GSK233705 20 micrograms, GSK233705 100 micrograms, Placebo and GSK233705 50 micrograms.
Subjects receiving treatment sequence 16EXPERIMENTALEligible subjects will receive treatment sequence 16; GSK233705 20 micrograms, GSK233705 100 micrograms, GSK233705 50 micrograms and Placebo.
Interventions
NameTypeDescription
PlaceboDRUGmatching placebo
GSK233705/GW642444DRUGThe combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.
GSK233705 12.5mcgDRUGOnce daily via dry powder inhaler
GSK233705 25mcgDRUGonce daily via dry powder inhaler
GSK233705 50mcgDRUGOnce daily via dry powder inhaler
GSK233705 100mcgDRUGOnce daily via dry powder inhaler
GSK233705 200mcgDRUGOnce daily via dry powder inhaler
GSK233705DRUG -
GSK233705 and GW642444DRUGInhaled Long acting muscarinic receptor antagonist (LAMA) and a inhaled Long acting Beta 2 agonist (LABA) both in development as treatment for Chronic Obstructive Pulmonary Disease, taken in combination.
GW642444DRUGInhaled Long acting Beta 2 agonist (LABA)
TiotropiumDRUGTiotropium will be given orally as overfoiled strips of 5 capsules, each containing 18 micrograms of tiotropium (as bromide monohydrate) administered via a HandiHaler device.
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Eligibility Criteria
Age Range40 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * male and females 40 to 80 years of age (inclusive) * COPD diagnosis * Current or previous smokers with a cigarette smoking history of at least 10 pack- * Post-albuterol FEV1/FVC of 0.70 or less * Post-albuterol FEV1 of 35% to 80% (inclusive) Exclusion Criteria: * Pregnant or...

Countries:United StatesArgentinaBulgariaCanadaChileGermanyHungaryNetherlandsPhilippinesRomaniaSouth AfricaSouth KoreaThailandUnited KingdomBelgiumSwedenJapan
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