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TAK-418

Phase 1

Healthy Participants | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Sep 9, 2019

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 Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03228433A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy ParticipantsPHASE1 COMPLETED 40 — — Jul 21, 2017May 12, 2018Sep 9, 20191 United States
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Study Endpoints
Primary Endpoints
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
Baseline Up to Day 184
Number of Participants Who Discontinued Due to an Adverse Event (AE)
Baseline Up to Day 184
Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose
Baseline Up to Day 184
Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Baseline Up to Day 184
Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Baseline Up to day 184
Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose
Baseline Up to Day 14
Secondary Endpoints
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base)
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-418F
Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
Cohort 1: TAK-418 5 mgEXPERIMENTALTAK-418 5 milligram (mg), capsule, orally, once on Day 1.
Cohort 2: TAK-418 15 mgEXPERIMENTALTAK-418 15 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg FedEXPERIMENTALTAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
Cohort 4: TAK-418 40 mgEXPERIMENTALTAK-418 40 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
Cohort 5: TAK-418 60 mgEXPERIMENTALTAK-418 60 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts.
Cohorts 1-5: PlaceboPLACEBO_COMPARATORTAK-418 placebo-matching, capsule, orally, once on Day 1.
Interventions
NameTypeDescription
TAK-418DRUGTAK-418 Capsule.
TAK-418 PlaceboDRUGTAK-418 placebo-matching capsules.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m\^2) at the Screening Visit. 2. Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months ...

Countries:United States
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