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TD-1439

Phase 1

Healthy Adults, Elderly Subjects | Small molecule | Other |Theravance Biopharma, Inc.|Last Updated: Jan 20, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02954263Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly SubjectsPHASE1 COMPLETED 40 — — Nov 1, 2016Apr 1, 2017Jan 20, 20211 United States
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Study Endpoints
Primary Endpoints
The number of adverse events by severity, including changes in vital signs, physical examination, laboratory safety tests, and ECGs.
From Day 1 through end of study (Day 25)
Secondary Endpoints
Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)
Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)
Day 1 to 3 days after last dose (Day 17)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
TD-1439EXPERIMENTALCapsule formulation
PlaceboPLACEBO_COMPARATORCapsule formulation
Interventions
NameTypeDescription
TD-1439DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range19 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) 18 to 32 kg/m2 inclusive * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control * Women of non-childbearing potential are at least 2 years postmenopausal or are s...

Countries:United States
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