A Study of TAK-951 in Healthy Adults

Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax.

Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)

Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study.

The criteria for markedly abnormal values of 12-lead ECG parameters were: ECG Mean Heart Rate (beats/min) \<50 beats per minute and \>120 beats per minute; PR Interval, Aggregate \[milliseconds (msec)\] \<=80 msec and \>=200 msec; QRS Duration, Aggregate (msec) \<=80 msec and \>=120 msec; QT Interval with Fridericia Correction Method (QTcF) Interval, Aggregate (msec) \>=500 msec or \>=30 msec change from Baseline and \>=450 msec. Only categories with atleast one participant with event are reported.

Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)

Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number.

The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) \>3xupper limit of normal(ULN); Albumin\<2.5g/dL,\<25g/L; Alkaline phosphatase (U/L)\>3 x ULN; Aspartate aminotransferase (U/L)\>3 x ULN; Bilirubin\>1.5mg/dL, \>34.2 µmol/L; Calcium\<8.0 mg/dL,LLN-\<2.0mmol/L, \>1.0mmol/L; Carbon dioxide \<8.0 (mmol/L); Chloride\<75 mmol/L,\>126 mmol/L; Creatinine\>177µmol/L; Gamma glutamyl transferase (U/L)\>2.0 mg/dL, \>3.0 x ULN; Glucose\<3 mmol/L,\>10 mmol/L; Potassium\<3.0 mmol/L \>5.5 mmol/L; Protein(g/L)\<0.8 x LLN \>1.2 x ULN; Sodium\<130mmol/L \>150mmol/L; Urea nitrogen \>10.7; Erythrocytes 10\^12erythrocytes/L) \<0.8 x LLN,\>1.2 x ULN; Hematocrit(%) \<0.8 x LLN,\>1.2xULN; Hemoglobin(g/L)\<0.8 x LLN, \>1.2 x ULN; Leukocytes(10\^9 leukocytes/L)\<0.5 x LLN \>1.5 x ULN; platelets(10\^9 platelets/L)\<75-\>600. Only categories with atleast one participant with event are reported.

Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)

Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study.

The criteria for markedly abnormal values of vital signs' parameters were: Pulse Rate (beats/minute) \<50 and \>120; Systolic Blood Pressure \[millimeters of mercury (mmHg)\] \<85 and \>180; Diastolic Blood Pressure (mmHg) \<50 and \>110; Temperature \[degrees Celsius (C)\] \<35.6 and \>37.7. Only categories with atleast one participant with events are reported.

Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)

Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number.

Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)

Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can 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 is considered related to the drug. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.

Time frame: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)

Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number.

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1

Population: PK Set (Part 1) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 1. Two participants were excluded from the overall number analyzed from 'Part 1 (SRD): Cohort 6: TAK-951 Dose 6' arm as their values were derived from poorly estimated elimination phase during the analysis.

Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1

Population: Part 1: Pharmacokinetic (PK) Set included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 1.

Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3

Population: PK Set (Part 3) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 3.

Time frame: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3

Population: PK Set (Part 3) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 3.