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TAK-114

Phase 1

Clinical Pharmacology | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jul 25, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment82

FDA Designations

No designations recorded

Clinical trial landscape

TAK-114 · 1 trial · 1 indication

Phase 1 1
NCT02286518TAK-114 Single- and Multiple-Dose Phase 1 StudyClinical Pharmacology
COMPLETED82 Analytics
PHASE1COMPLETED
TAK-114 Single- and Multiple-Dose Phase 1 Study
Clinical Pharmacology
NCT0228651882
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Study Endpoints

Primary Endpoints

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Baseline up to 3 days after the last dose of study drug (Day 3 in Part 1), (Day 20 in Part 2) and 7 days after the last dose of study drug (Day 17 in Part 3)
Number of Participants With TEAEs Related to Vital Signs
Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With TEAEs Related to Body Weight
Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3
Number of Participants With Clinically Meaningful Changes From Baseline in 12-lead Electrocardiograms (ECG)
Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported.

Number of Participants With TEAEs Categorized Into Investigations System Organ Class (SOC) Related to Chemistry, Hematology or Urinalysis
Baseline up to Day 3 in Part 1, Day 20 in Part 2 and Day 17 in Part 3

Secondary Endpoints

Cmax - Maximum Observed Plasma Concentration for TAK-114
Day1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1:predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2; Day 10:predose and at multiple time points (up to 12 hours) postdose for Part 3
AUC (0-Infinity) - Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for Unchanged TAK-114: Part 1 and Part 2
Day 1: predose and at multiple time-points (up to 48 hours) postdose for Part 1; Day 1: predose and at multiple time-points (up to 48 hours) postdose in each period for Part 2
AUC (0-tau) - Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau for TAK-114: Part 3
Day10: predose and at multiple time points (up to 12 hours) postdose for Part 3
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1A: TAK-114 10 mgEXPERIMENTALOrally, once only.
Cohort 1B: TAK-114 10 mgEXPERIMENTALOrally, once
Cohort 2A: TAK-114 20 mgEXPERIMENTALOrally, once
Cohort 2B: TAK-114 20 mgEXPERIMENTALOrally, once
Cohort 3A: TAK-114 50 mgEXPERIMENTALOrally, once
Cohort 3B: TAK-114 50 mgEXPERIMENTALOrally, once
Cohort 4a: TAK-114 20 mgEXPERIMENTALPeriod 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast
Cohort 4b: TAK-114 20 mgEXPERIMENTALPeriod 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state
Cohort 5A: TAK-114 20 mgEXPERIMENTALOrally, Twice daily, 10 days
Cohort 5B: TAK-114 20 mgEXPERIMENTALOrally, Twice daily, 10 days
Cohort 6A: TAK-114 50 mgEXPERIMENTALOrally, Twice daily, 10 days
Cohort 6B: TAK-114 50 mgEXPERIMENTALOrally, Twice daily, 10 days
Cohort 1A, 2A, 3A: TAK-114 placeboPLACEBO_COMPARATORCohort 1A, 2A, 3A: Orally, once
Cohort 5A: TAK-114 placeboPLACEBO_COMPARATORCohort 5A: Orally, Twice daily, 10 days
Cohort 6A: TAK-114 placeboPLACEBO_COMPARATORCohort 6A: Orally, Twice daily, 10 days

Interventions

NameTypeDescription
TAK-114 10 mg capsuleDRUG -
TAK-114 matched placeboDRUG -
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Eligibility Criteria

Age Range20 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy Japanese participants: * Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol. * Is aged 20 to 45 years, inclusive. * Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 a...

Countries:Japan
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Frequently asked questions about TAK-114

What is TAK-114?

TAK-114 is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited. It is currently in Phase 1 clinical development for clinical pharmacology studies. The drug is being studied in healthy volunteers to evaluate its safety and tolerability.

Who makes TAK-114?

TAK-114 is being developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. The company is conducting clinical trials of TAK-114 in Japan.

What phase is TAK-114 in?

TAK-114 is in Phase 1 clinical development. A completed Phase 1 study evaluated single and multiple doses of the drug in healthy male volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is TAK-114 in?

TAK-114 has one completed Phase 1 clinical trial, identified as NCT02286518. This study was a single- and multiple-dose trial conducted in Japan with 82 healthy male participants aged 20 years and older. The trial was randomized, double-blind, and placebo-controlled.

Is TAK-114 FDA approved?

TAK-114 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial focused on clinical pharmacology in healthy volunteers, and the drug has not yet progressed to later-stage trials or regulatory approval.