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TAK-510

Phase 1

Healthy Participants | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Mar 4, 2024

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 Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04731922A Study of TAK-510 in Healthy AdultsPHASE1 COMPLETED 124Feb 3, 2021Jul 24, 2022Mar 4, 20242 United States
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Study Endpoints
Primary Endpoints
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
Parts 1 and 2: From the first dose of study drug up to Day 29

Vital signs included systolic and diastolic blood pressure, body temperature, pulse rate (PR), respiratory rate, orthostatic blood pressure and pulse rate assessments. The markedly abnormal value (MAV) criteria for vital signs were systolic blood pressure (SBP) less than (\<) 85 millimeter of mercury (mmHg), greater than (\>) 180 mmHg; diastolic blood pressure (DBP) \<50 mmHg, \>110 mmHg; body temperature \<35.6 degree Celsius, \>37.7 degree Celsius; PR \<50 beats per minute (bpm), \>120 bpm; respiratory rate \<12 breaths per minute (breaths/minute), \>16 breaths/minute; orthostatic hypotension decrease in SBP greater than or equal to (\>=) 20 mmHg or a decrease in DBP \>=10 mmHg on standing; orthostatic tachycardia defined as an increase of \>30 bpm or heart rate (HR) \>120 bpm on standing. Number of participants who met the MAV criteria for vital signs at least once post dose were reported.

Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose
Parts 1 and 2: From the first dose of study drug up to Day 29

ECG included HR, PR, QT interval with Fridericia correction (QTcF) interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate \<50 bpm, \>120 bpm; PR interval less than or equal to (\<=)80 milliseconds (msec), \>=200 msec; QTcF interval \>=500 msec; QRS duration \<=80 msec, \>=120 msec. Number of participants who met the MAV criteria for ECG parameters at least once post dose were reported.

Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose
Parts 1 and 2: From the first dose of study drug up to Day 29

Clinical laboratory parameters included tests for chemistry and hematology. The MAV criteria for laboratory value included hemoglobin \<0.8\*LLN,\>1.2\*ULN; hematocrit \<0.8\*LLN,\>1.2\*ULN;RBC count \<0.8\*LLN, \>1.2\*ULN;WBC count \<0.5\*LLN, \>1.5\*ULN; platelet count \<75\*10\^9 per liter, \>600\*10\^9 per liter; ALT \>3\*ULN; AST \>3\*ULN,GGT \>3\*ULN, normal baseline; \>2\*baseline,abnormal baseline; ALP\>3\*ULN, normal baseline; \>2\*baseline, abnormal baseline; total bilirubin \>1.5\*ULN, normal baseline; \>1.5\* baseline, abnormal baseline; albumin \<25g/L; total protein \<0.8\* LLN, \>1.2\*ULN; creatinine \>177 micromole per liter; blood urea nitrogen \>10.7 mmol/L; sodium \<130 mmol/L, \>150mmol/L; potassium \<3.0mmol/L, \>5.5 mmol/L; glucose \<3mmol/L, \>10mmol/L; chloride \<75mmol/L, \>126mmol/L; calcium corrected serum calcium of \<LLN-8.0 mg/dL; \<LLN-2.0mmol/L; ionized calcium \<LLN-1.0mmol/L; bicarbonate \<8.0mmol/L. Number of participants who met the MAV criteria for laboratory value at least once post dose were reported.

Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
From the first dose of study drug until 30 days after last dose in Parts 1 and 2 (SRD Cohorts: up to Day 31, MRD Cohorts: up to Day 35)

A TEAE was defined as an adverse event (AE) that started or worsened after first dose of the study treatment and within 30 days of last dose of study treatment. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it did not necessarily had to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug.

Secondary Endpoints
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for ECG Parameters at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Part 3: From the first dose of study drug up to Day 29
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Part 3: From the first dose of study drug up to Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeOTHER
Treatment Arms
ArmTypeDescription
TAK-510: Part 1EXPERIMENTALTAK-510 at starting dose of 5 microgram (mcg) or placebo-matching solution, subcutaneously, once on Day 1. Staggered dosing will be done in the first cohort of Part A (Cohort 1). Staggered dosing in subsequent Cohorts (Cohorts 2-12 and 21-25) will be used based on emerging safety, tolerability, and PK data from Cohort 1 as determined in the dose escalation meeting.
TAK-510: Part 2EXPERIMENTALTAK-510 to be decided (TBD) or placebo-matching solution, subcutaneously, once daily from Day 1 through Day 5. Dose of MRD Cohorts (Cohorts 13-17 and 26-28) of Part 2 will be determined based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and any available PK data from Part 2 as determined in the dose escalation meeting.
TAK-510: Part 3EXPERIMENTALTAK-510 TBD or placebo-matching solution, subcutaneously, once daily from Days 1 to 7. Dose of dose titration and redosing Cohorts (Cohorts 18-20) of Part 3 will be based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and Part 2 (MRD) as determined in the dose escalation meeting. Single redosing will be performed on Day 14 after 7 days of washout period following the 7 days treatment period.
Interventions
NameTypeDescription
TAK-510DRUGTAK-510 solution.
TAK-510 PlaceboDRUGTAK-510 placebo-matching solution.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study. * Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 30.0 kilogram per square meter (kg/m\^2) ...

Countries:United States
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