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-TAK-954

Phase 1

Healthy Volunteers | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Jun 24, 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-BlindCONTROLLEDBiomarker
Total Trials2
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03500224A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male ParticipantsPHASE1 COMPLETED 6 — — Apr 30, 2018Jun 1, 2018Jul 29, 20191 Netherlands
NCT03870555A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult ParticipantsPHASE1 COMPLETED 6 — — Mar 8, 2019May 16, 2019Jun 24, 20201 United States
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Study Endpoints
Primary Endpoints
Cumulative Percentage of Administered Radioactivity Recovered in Urine
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Administered Radioactivity Recovered in Feces
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Radioactivity in Urine and Feces Combined
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine and Feces Combined
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.

Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Urine
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.

Normalized Recovery as Percentage of Dose for TAK-954 and TAK-954 Metabolites in Feces
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

Percentage of dose recovered for TAK-954 and its metabolites derived from 0-168 hour sampling was normalized for 100% recovery.

Mean Percent of Total Radioactivity in Plasma for TAK-954 and TAK-954 Metabolites
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose
Cumulative Percentage of Dose Excreted in Urine for TAK-954
Day 1 pre-dose and at multiple time points (up to 264, 312, and 336 hours) post-dose
Cumulative Percentage of Dose Excreted in Feces for TAK-954
Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose

The cumulative percentage of dose excreted in feces as TAK-954 derived from 0-168 hour sampling was normalized for 100% recovery.

Mean Concentration of Total Radioactivity in Whole Blood and Plasma [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma and Whole Blood Concentrations of Radioactivity for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Cmax: Maximum Observed Plasma Concentration for TAK-954 and TAK-954 Metabolites
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to the Time of the Last Quantifiable Radioactivity for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 and TAK-954 Metabolites
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma and Whole Blood Radioactivity-time Curve From Time 0 to Infinity for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 and TAK-954 Metabolites
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma and Whole Blood Radioactivity for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-954 and TAK-954 Metabolites
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life of Radioactivity in Plasma and Whole Blood for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
t1/2z: Terminal Disposition Phase Half-life in Plasma for TAK-954 and TAK-954 Metabolites
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance of TAK-954 After Intravenous Administration of [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Urine: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Aet Feces: Amount of Total Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Urine: Fraction of Total Radioactivity Excreted in Urine From Time 0 to Time t for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Fet Feces: Fraction of Radioactivity Excreted in Feces From Time 0 to Time t for [14C]-TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954
Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954
Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954
Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954
Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954
Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954
Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for TAK-954
Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose
Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose
Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose
Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose
Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose
Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose
Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
CLR: Renal Clearance for TAK-954
Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Secondary Endpoints
Ratio of Total Radioactivity in Whole Blood to Plasma
Day 1 pre-dose and at multiple time points (up to 264 hours) post-dose
Ratio of AUC∞: Ratio of Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 to Total Radioactivity in Plasma TAK-954
Day 1 pre-dose and at multiple time points (up to 336 hours) post-dose
Percentage of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)
Baseline up to Day 31
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
[14C]-TAK-954 0.5 mgEXPERIMENTAL\[14C\]-TAK-954 0.5 milligram (mg), (containing approximately 1.5 microcurie \[µCi\] of radioactive tracer), administered as 60-minute infusion, intravenously, once on Day 1.
Sequence 1EXPERIMENTALPeriod 1: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 2: TAK-954 0.1 milligram (mg), infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.
Sequence 2EXPERIMENTALPeriod 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg, infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.
Sequence 3EXPERIMENTALPeriod 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg, infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg, infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. A washout period of at least 16 days will be maintained between each Treatment Period.
Interventions
NameTypeDescription
[14C]-TAK-954DRUG\[14C\]-TAK-954 intravenous infusion.
TAK-954DRUGTAK-954 infusion administered intravenously.
TAK-954 PlaceboDRUGTAK-954 placebo-matching infusion intravenous.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Be a man aged 18 to 55 years, inclusive, at the screening visit. 2. Have a body mass index (BMI) greater than or equal to (\>=) 18 and less than or equal to (\<=) 30 kilogram per square meter (kg/m\^2) and a body weight greater than (\>) 50 kilogram (kg) at the screening visi...

Countries:NetherlandsUnited States
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