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TAK-491

Phase 1

Healthy Volunteer | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Feb 5, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

TAK-491 · 1 trial · 1 indication

Phase 1 1
NCT02541669A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese ParticipantsHealthy Volunteer
COMPLETED64 Analytics
PHASE1COMPLETED
A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants
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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 to 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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Frequently asked questions about TAK-491

What is TAK-491 used for?

TAK-491 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics in healthy Chinese participants. TAK-491 is not approved for any indication and remains under clinical investigation.

Who makes TAK-491?

TAK-491 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy volunteers.

What phase is TAK-491 in?

TAK-491 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is not yet approved. It remains investigational and is being studied in healthy volunteers to assess its pharmacokinetics.

What clinical trials is TAK-491 in?

TAK-491 has one completed Phase 1 trial, NCT02541669, titled 'A Single- and Multiple-Dose Study of the Pharmacokinetics of TAK-491 in Healthy Chinese Participants.' The trial enrolled 64 participants in China and was randomized, double-blind, and placebo-controlled.

Is TAK-491 FDA approved?

TAK-491 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT02541669, was a pharmacokinetic study in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.