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TAK-114

Phase 1

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

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 Enrollment82
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02286518TAK-114 Single- and Multiple-Dose Phase 1 StudyPHASE1 COMPLETED 82 — — Nov 1, 2014Apr 1, 2015Jul 25, 20161 Japan
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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 — 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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