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GSK961081 SD

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
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00887406Study of GSK961081 in Healthy Volunteer SubjectsPHASE1 COMPLETED 46 — — Nov 7, 2005Oct 4, 2006Oct 6, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
General safety and tolerability (adverse events, clinical laboratory safety tests, cardiac monitoring, vital signs (including postural changes in blood pressure), 12-lead ECG parameters including QTc(b) and QTc(f), blood glucose and serum potassium).
Pre and post-dose on Days 1, 4 and 7
Secondary Endpoints
Maxiumum and weighted mean (over 0-8 hours post-dose) for systolic and diastolic blood pressure, heart rate, QTc(F), QTc(B), plasma glucose and serum potassium
Days 1, 4 and 7
specific airway conductance (sGaW)
pre and post-dose on Days 1, 4 and 7
forced expiratory volume in one second (FEV1)
Pre and post-dose on Days 1, 4 and 7
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1, Period 2EXPERIMENTALGSK961081 3mcg, Placebo, GSK961081 15mcg, GSK961081 50mcg
Cohort 1, period 1EXPERIMENTALPlacebo, GSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg
Cohort 1, period 3EXPERIMENTALGSK961081 3mcg, GSK961081 15mcg, Placebo, GSK961081 50mcg
Cohort 1, period 4EXPERIMENTALGSK961081 3mcg, GSK961081 15mcg, GSK961081 50mcg, Placebo
Cohort 2, period 1EXPERIMENTALPlacebo, GSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg,
Cohort 2, period 2EXPERIMENTALGSK961081 100mcg, Placebo, GSK961081 200mcg, GSK961081 300mcg
Cohort 2, period 3EXPERIMENTALGSK961081 100mcg, GSK961081 200mcg, Placebo, GSK961081 300mcg
Cohort 2, period 4EXPERIMENTALGSK961081 100mcg, GSK961081 200mcg, GSK961081 300mcg, Placebo
Cohort 3EXPERIMENTALGSK961081 100mcg or Placebo
Cohort 4EXPERIMENTALGSK961081 300mcg or Placebo
Interventions
NameTypeDescription
GSK961081 15mcg SDDRUGSingle dose delivered via solution for nebulisation
GSK961081 3mcg SDDRUGsingle dose delivered via nebulsier
GSK961081 50mcg SDDRUGsingle dose delivered via solution for nebulisation
Placebo SDDRUGsingle dose via nebuliser
GSK961081 100mcg SDDRUGsingle dose delivered via solution for nebulisation
GSK961081 200mcg SDDRUGsingle dose via nebuliser
GSK961081 300mcg SDDRUGsingle dose via nebuliser
GSK961081 100mcg RDDRUGrepeat dose via nebuliser
GSK961081 300mcg RDDRUGrepeat dose vai nebuliser
Placebo RDDRUGrepeat dose via nebuliser
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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 18.5-29.9 kilograms/meter2 (kg/m2). * Forced Expiratory Volume in 1 second (FEV1) \<80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \<0.7 * Response to Salbutamol defined as: an in...

Countries:United Kingdom
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