A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants

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 is defined as an AE with an onset that occurs after receiving study drug.

Time frame: Baseline up to 30 days after the last dose (Up to 48 days)

Population: Safety set included all randomized participants who received at least 1 dose of study drug.

A 12-lead ECG was performed. Markedly abnormal values during treatment period were categorized as: ECG Mean Heart Rate (beats/min) \<50-\>120, PR Interval, Aggregate (msec) \<=80-\>=200, QRS Duration, Aggregate (msec) \<=80-\>=180, QT Interval, Aggregate (msec) \<=300-\>=460, QTcF Interval, Aggregate (msec) \<=300-\>=500 OR \>=30 change from baseline and \>=450 milliseconds.

Time frame: Baseline up to 30 days after the last dose (Up to 48 days)

Population: Safety set included all randomized participants who received at least 1 dose of study drug.

Clinical Laboratory parameters included tests for chemistry, hematology and urinalysis. Markedly abnormal values during treatment period were categorized as: alanine aminotransferase (ALT)\>3.0 U/L\*upper limit of normal(ULN), albumin\<25 g/L, alkaline phosphatase \>3.0 U/L\*ULN, aspartate aminotransferase \>3.0 U/L\*ULN, bilirubin \>3.42 umol/L creatinine \>177umol/L, gamma glutamyl transferase (GGT) \>3 U/L\*ULN, glucose \<2.8 mmol/L, \>19.4 mmol/L, potassium\<3 mmol/L, \>6 mmol/L, sodium \<130 mmol/L, \>150 mmol/L, protein \<0.8 g/L,\* lower limit of normal (LLN), \>1.2 g/L\*ULN, erythrocytes \<0.8 (10\^12/L)\*LLN, \>1.2 (10\^12/L)\*ULN, hematocrit (%) \<0.8\*LLN, \>1.2\*ULN, hemoglobin \<0.8 g/L\*LLN, \>1.2 g/L\*ULN, leukocytes \<0.5 (10\^9/L)\*LLN, \>1.5 (10\^9/L)\*ULN, platelets \<75(10\^9/L), \>600(10\^9/L). Only categories with values have been reported.

Time frame: Baseline up to 30 days after the last dose (Up to 48 days)

Population: Safety set included all randomized participants who received at least 1 dose of study drug.

Vital signs included temperature, pulse rate and blood pressure. Markedly abnormal values during treatment period were categorized as: Pulse Rate (beats/min) \<50-\>120, Systolic Blood Pressure (SBP) (mmHg) \<85-\>180, Diastolic Blood Pressure (DBP) (mmHg) \<50-\>110 and Temperature (degree centigrades) \<35.6- \>37.7.

Time frame: Baseline up to 30 days after the last dose (Up to 48 days)

Population: Safety set included all randomized participants who received at least 1 dose of study drug.

Time frame: 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16

Population: The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration with data available for this outcome measure.

Time frame: 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 1

Population: The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration.

Time frame: 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Day 16

Population: The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration with data available for this outcome measure.

Time frame: 0.5 hours pre-dose and at multiple timepoint (Up to 24 hours) post-dose on Days 1 and 16

Population: The PK set included all participants from the safety set who had at least 1 measurable post dose TAK-831 plasma concentration. Number analyzed is the number of participants with data available for analysis for the given timepoint.