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TAK-491

Phase 1

Healthy Volunteer | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Feb 5, 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 Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02541669A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese ParticipantsPHASE1 COMPLETED 64 — — Nov 20, 2015Mar 17, 2017Feb 5, 20201 China
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Study Endpoints
Primary Endpoints
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-536 (the Active Moiety Derived From TAK-491) on Day 10
Day 10 pre-dose and at multiple time points (up to 24 hours) post-dose
Terminal Phase Elimination Half-life (T1/2) for TAK-536 (the Active Moiety Derived From TAK-491) on Day 1
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER
Treatment Arms
ArmTypeDescription
TAK-491 40 mg (Open Label)EXPERIMENTALTAK-491 40 milligram (mg), tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
TAK-491 80 mg (Open-label)EXPERIMENTALTAK-491 80 mg, tablet, orally, once daily on Day 1 and Days 4 to 10 as an open-label treatment.
TAK-491 40 mg (Double-blind)EXPERIMENTALTAK-491 40 mg, tablet, orally, once daily and TAK-491 80 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 in double-blind manner.
TAK-491 80 mg (Double-blind)EXPERIMENTALTAK-491 80 mg, tablet, orally, once daily and TAK-491 40 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10 in double-blind manner.
PlaceboPLACEBO_COMPARATORTAK-491 40 mg placebo-matching tablet, orally, once daily and TAK-491 80 mg placebo-matching tablet, orally, once daily on Day 1 and Days 4 to 10.
Interventions
NameTypeDescription
TAK-491DRUGTAK-491 tablets
TAK-491 placeboDRUGTAK-491 placebo-matching tablets
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study pro...

Countries:China
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