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TD-1211 Dose 1

Phase 1

Constipation | Small molecule | Gastrointestinal |Theravance Biopharma, Inc.|Last Updated: Jan 14, 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
CONTROLLED
Total Trials1
Total Enrollment47
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01655771TD-1211 Single-Dose Study in Elderly and Young Healthy SubjectsPHASE1 COMPLETED 47 — — Aug 1, 2012Mar 1, 2013Jan 14, 20211 United States
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Study Endpoints
Primary Endpoints
Cmax
0-96 hours
AUCt
Based on samples collected 0-96 hours
AUCinf
Based on samples collected 0-96 hours
Secondary Endpoints
Number of patients with treatment-emergent adverse events
Days 1-14
Number patients with abnormal vital sign measurements
Days 1-5
Number of patients with abnormal clinical laboratory results
Days 1-5
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ElderlyEXPERIMENTALTD-1211 Dose 1
YoungerEXPERIMENTALTD-1211 Dose 2
Interventions
NameTypeDescription
TD-1211 Dose 1DRUG -
TD-1211 Dose 2DRUG -
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive. * Body mass index (BMI) should be 18 to 36 kg/m2, inclusive. * At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supi...

Countries:United States
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