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GSK961081

Phase 1

Pulmonary Disease, Chronic Obstructive | Small molecule | Other |Theravance Biopharma, Inc.|Last Updated: Oct 6, 2021

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 Trials2
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00687700A Study to Investigate the Pharmacology of a Dual Pharmacophore in Healthy VolunteersPHASE1 COMPLETED 23 — — Mar 10, 2008May 27, 2008Oct 6, 20211 United Kingdom
NCT00550225Succinate Salt Version of GSK961081 for Healthy VolunteersPHASE1 COMPLETED 18 — — Nov 29, 2007Jan 8, 2008Oct 6, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
To assess the bronchodilation of single doses of GSK961081 over 24 hours following ß blockade with the ß antagonist propranolol as measured by sGaw in healthy subjects.
Up to 32 hours
FEV1 at intervals
during the 10 week study
Cardiac monitoring at intervals
during the 10 week study
Secondary Endpoints
Assess safety of GSK961081 after single doses of it with&without ß blockade with propranolol as measured by specific indicators
Up to 71 days
Adverse events, clinical laboratory safety tests, FEV1, vital signs, 12-lead ECG parameters, blood glucose and serum potassium.
Up to 71 days
Propranolol and GSK961081blood levels to derive pharmacokinetics
Up to 32 hours
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Study Design & Arms
AllocationRANDOMIZED
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
All subjectsEXPERIMENTALEligible subjects will receive GSK961081 (400 micrograms or 1200 micrograms), GSK961081 matching placebo, propranolol (80 milligrams) and propranolol matching placebo in five treatment sessions through ten different crossover treatment sequences. There will be a washout period between treatment sessions of 7 to 14 days.
Sequence 1EXPERIMENTALIn session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
Sequence 2EXPERIMENTALIn session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
Sequence 3EXPERIMENTALIn session 1, subjects will receive 300 microgram GSK961081 succinate followed by placebo in session 2. The subjects will receive 1500 micrograms of GSK961081edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
Sequence 4EXPERIMENTALIn session 1, subjects will receive 300 microgram GSK961081 succinate followed by 1500 micrograms of GSK961081 edisylate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
Sequence 5EXPERIMENTALIn session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and placebo in session 4.
Sequence 6EXPERIMENTALIn session 1, subjects will receive placebo followed by 900 micrograms of GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 succinate in session 3 and 1500 micrograms of GSK961081 edisylate in session 4.
Sequence 7EXPERIMENTALIn session 1, subjects will receive 1500 micrograms of GSK961081 edisylate followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive placebo in session 3 and an additional dose of GSK961081 succinate in session 4.
Sequence 8EXPERIMENTALIn session 1, subjects will receive placebo followed by 900 microgram GSK961081 succinate in session 2. The subjects will receive 1500 micrograms of GSK961081 edisylate in session 3 and an additional dose of GSK961081 succinate in session 4.
Interventions
NameTypeDescription
GSK961081DRUGGSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning.
GSK961081 matching placeboDRUGGSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning.
PropranololDRUGPropranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water.
Propranolol matching placeboDRUGPropranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water.
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Eligibility Criteria
Age Range18 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult males aged between 18 and 50 years. * Body mass index within the range 19-29.9 kg/m2. * FEV1 ≥ 80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio ≥ 0.7 * Signed and dated written informed consent is obtained from the subject * The subject is able to unde...

Countries:United Kingdom
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