Healthy Participants
Conditions
Keywords
Drug Therapy
Brief summary
This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting). The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it. The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the study. At the first visit, the study doctor will check if each person can take part. For those who can take part, they will be placed in 1 of many small groups. The 1st groups will join Part 1 of the study, the 2nd groups will join Part 2 and the 3rd groups will join Part 3. They will receive an injection under the skin of either TAK-510 or placebo. In this study, a placebo will look like the TAK-510 injection but will not have any medicine in it. In Part 1, the 1st group of participants will receive 1 injection of either TAK-510 or placebo. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment. In Part 2, the 2nd group of participants will receive an injection of either TAK-510 or placebo, once a day for 5 days. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment. In Part 3, the 3rd group of participants will visit the clinic 2 times. At the 1st visit, they will receive an injection either of TAK-510 or placebo, once a day for 7 days. Each participant in this group will receive lower to higher doses of TAK-510. They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment. At the 2nd clinic visit, each participant will receive 1 single injection of TAK-510 or placebo. This will happen 7 days after their last injection from the previous clinic visit. They will receive the same dose as their previous dose. They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment. After treatment, all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks.
Detailed description
The drug being tested in this study is called TAK-510. The study will look at the safety, tolerability, and PK of TAK-510 in healthy participants. The study will enroll up to approximately 224 healthy participants. Participants in each cohort will be randomized to receive treatment with TAK-510 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). The study consists of 3 parts and up to 28 cohorts as mentioned below. * TAK-510, Part 1: Single rising dose (SRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510 * TAK-510, Part 2: Multiple rising dose (MRD) design to assess the safety, immunogenicity, tolerability, and PK of TAK-510 * TAK-510, Part 3: Dose titration and redosing design to assess the safety, immunogenicity, tolerability, and PK of TAK-510 This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 57 days. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment.
Interventions
DRUGTAK-510
TAK-510 solution.
DRUGTAK-510 Placebo
TAK-510 placebo-matching solution.
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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) at the screening visit.
Exclusion criteria
* Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit. * Had major surgery or donated or lost 1 unit of blood (approximately 500 milliliter \[mL\]) within 4 weeks before the screening visit. * Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until 2 days after discharge. * Unable to refrain from or anticipates using marijuana or cannabis-containing products beginning approximately 7 days before administration of the first dose of study drug, throughout the study until after the last PK dose. * Has had a previous major psychotic disorder. * Has an average semirecumbent blood pressure (BP) less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive. Any assessments on Day -1, where 2 consecutive time point values do not meet this criterion must be discussed with the medical monitor for approval. * Has orthostatic hypotension defined as a decrease in systolic BP \>=20 mmHg or a decrease in diastolic BP \>=10 mmHg at approximately 3 minutes of standing when compared with BP from the semirecumbent position, at screening to predose assessments, inclusive. In asymptomatic participants, any assessments after screening that do not meet this criterion may be repeated after the participant has remained in the semirecumbent or supine position for 15 minutes. If the repeat assessment is exclusionary based on the above criterion, the participant will not be eligible. If the repeat assessment is not exclusionary, the participant will be eligible. * Has postural orthostatic tachycardia, defined as an increase of greater than (\>) 30 beats per minute (bpm) or heart rate (HR) \>120 bpm at approximately 3 minutes, of standing, at screening to predose assessments, inclusive. Any assessments after screening that do not meet this criterion may be repeated with the participant remaining standing for up to a total of 5 minutes, provided that the participant remains asymptomatic. If the repeat assessment occurring within 5 minutes is exclusionary based on the above criterion, the participant will not be eligible. A confirmed orthostatic increase of \>30 bpm, but less than (\<) 40 bpm, on 1 or more Day -1 assessments may not be considered exclusionary if not considered clinically significant by the investigator and the medical monitor. Such assessments must be discussed with the medical monitor prior to determination that the participant is eligible to proceed. * Has a known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | Parts 1 and 2: From the first dose of study drug up to Day 29 | A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment. |
| Part 3: Number of Participants Based on ADA Status (Positive and Negative) in Serum | Part 3: From the first dose of study drug up to Day 29 | A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3. |
| 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 | Vital signs included systolic and diastolic blood pressure, body temperature, PR, respiratory rate, orthostatic blood pressure and pulse rate assessments. The MAV criteria for vital signs were systolic SBP \< 85 mmHg, \>180 mmHg; DBP \<50 mmHg, \>110 mmHg; body temperature \<35.6 degree Celsius, \>37.7 degree Celsius; PR \<50 bpm, \>120 bpm; respiratory rate \<12 breaths/minute, \>16 breaths/minute; orthostatic hypotension decrease in SBP \>=20 mmHg or a decrease in DBP \>=10 mmHg on standing; orthostatic tachycardia defined as an increase of \>30 bpm or HR \>120 bpm on standing. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3. |
| Part 3: Number of ADA Positive Participants Based on Low or High ADA Titer | Part 3: From the first dose of study drug up to Day 29 | The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer \>16 and low ADA titer was defined as participant whose postbaseline ADA titers are all \<=16. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3. |
| Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | Parts 1 and 2: From the first dose of study drug up to Day 29 | The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer \>16 and low ADA titer was defined as participant whose postbaseline ADA titers are all \<=16. The low or high ADA titer was assessed in ADA positive participants only. |
| 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 | ECG included HR, PR, QT QTcF interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate \<50 bpm, \>120 bpm; PR interval \<=80 msec, \>=200 msec; QTcF interval \>=500 msec or \>=30 msec change from baseline and \>=450 msec; QRS duration \<=80 msec, \>=120 msec. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3. |
| 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 | MAV criteria: 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. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3. Hence, no data collection and assessment were done in Part 3. |
| Part 3, Number of Participants Reporting One or More TEAE Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens | Part 3: From the first dose of study drug until 30 days after last dose (up to Day 37) | A TEAE was defined as an 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. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Part 2, CL/F: Apparent Clearance After Extravascular Administration at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, Ctrough: Observed Plasma Concentration at the End of a Dosing Interval at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, Rac (AUC): Accumulation Ratio Based on AUCτ at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, Rac (Cmax): Accumulation Ratio Based on Cmax at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Parts 1 and 2, Cmax: Maximum Observed Plasma Concentration for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose; Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Parts 1 and 2, Aet1-t2: Amount of Drug Excreted in Urine From Time 1 to Time 2 for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; Part 2, Days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval (Tau) at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Parts 1 and 2, fe,t: Fraction of Administered Dose of Drug Excreted From Urine From Time 0 to Time t for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; Part 2, Days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Parts 1 and 2, CLR: Renal Clearance for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; Part 2, Days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Parts 1 and 2, Aet: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-510 | Parts 1 and 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Parts 1 and 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose; Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 1, T1/2z: Terminal Disposition Phase Half-life for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 1, CL/F: Apparent Clearance After Extravascular Administration for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 1, Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-510 | Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, AUCτ: Area Under the Plasma Concentration-time Curve Over a Dosing Interval for TAK-510 | Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, AUCτss: Area Under the Plasma Concentration-time Curve Over a Dosing Interval at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, Cmaxss: Maximum Observed Plasma Concentration at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, Tmaxss: Time to Reach the Maximum Observed Plasma Concentration at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
| Part 2, T1/2z: Terminal Disposition Phase Half-life at Steady State for TAK-510 | Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose | Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 2 investigative sites in the United States from 3 February 2021 to 24 July 2022.
Pre-assignment details
Healthy participants were enrolled in study into 2 Parts: Single Rising Doses (SRD) (Part 1) and Multiple Rising Doses (MRD) (Part 2) to receive TAK-510 placebo-matching or TAK-510 injection. Starting Dose 1 was 5 micrograms (mcg) and subsequent doses were increased from low dose to high dose for Doses 1-11 and Doses 1A-4A in Part 1 or Part 2, respectively. Study was completed after completion of Parts 1 and 2. Sponsor decided not to conduct Part 3 after comprehensive review of available data.
Participants by arm
| Arm | Count |
|---|---|
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo TAK-510 placebo-matching injection, subcutaneously, once on Day 1. | 23 |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 TAK-510 Dose 1, injection, subcutaneously, once on Day 1. | 6 |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 TAK-510 Dose 2, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort 1. | 6 |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 TAK-510 Dose 3, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 TAK-510 Dose 4, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 7 |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 TAK-510 Dose 5, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 TAK-510 Dose 6, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 TAK-510 Dose 7, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 TAK-510 Dose 8, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 TAK-510 Dose 9, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 TAK-510 Dose 10, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 TAK-510 Dose 11, injection, subcutaneously, once on Day 1. The dose of TAK-510 was based on 24-hours safety, tolerability, laboratory results and available PK data from previous SRD Cohort. | 6 |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo TAK-510 placebo-matching placebo, injection, subcutaneously from Days 1 to 5. | 8 |
| Part 2, MRD Cohort 12: Dose 1A TAK-510 Dose 1A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from SRD Part 1. | 8 |
| Part 2, MRD Cohort 13: Dose 2A TAK-510 Dose 2A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and available PK data from previous MRD Cohort. | 6 |
| Part 2, MRD Cohort 14: Dose 3A TAK-510 Dose 3A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort. | 6 |
| Part 2, MRD Cohort 15: Dose 4A TAK-510 Dose 4A, injection, subcutaneously from Days 1 to 5. The dose of TAK-510 was based on safety, tolerability, and available PK data from Part 1 and review of safety, tolerability, and PK data from previous MRD Cohort. | 6 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part 1, SRD Cohort 1: TAK-510 Dose 1 | Part 1, SRD Cohort 2: TAK-510 Dose 2 | Part 1, SRD Cohort 3: TAK-510 Dose 3 | Part 1, SRD Cohort 4: TAK-510 Dose 4 | Part 1, SRD Cohort 5: TAK-510 Dose 5 | Part 1, SRD Cohort 6: TAK-510 Dose 6 | Part 1, SRD Cohort 7: TAK-510 Dose 7 | Part 1, SRD Cohort 8: TAK-510 Dose 8 | Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Part 1, SRD Cohort 9: TAK-510 Dose 9 | Part 1, SRD Cohort 10: TAK-510 Dose 10 | Part 1, SRD Cohort 11: TAK-510 Dose 11 | Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Part 2, MRD Cohort 12: Dose 1A | Part 2, MRD Cohort 13: Dose 2A | Part 2, MRD Cohort 14: Dose 3A | Part 2, MRD Cohort 15: Dose 4A |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 124 Participants | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 23 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 8 Participants | 6 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 2 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 3 Participants | 5 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 4 Participants | 3 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 2 Participants | 3 Participants | 18 Participants | 6 Participants | 6 Participants | 3 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 1 Participants | 3 Participants | 3 Participants | 6 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 6 Participants | 3 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 7 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 51 Participants | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 12 Participants | 1 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 124 Participants | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 23 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 8 Participants | 6 Participants | 6 Participants | 6 Participants |
| Sex: Female, Male Female | 17 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 6 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 107 Participants | 3 Participants | 5 Participants | 6 Participants | 7 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 17 Participants | 5 Participants | 6 Participants | 5 Participants | 8 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 9 / 23 | 1 / 6 | 3 / 6 | 3 / 6 | 4 / 7 | 6 / 6 | 6 / 6 | 4 / 6 | 6 / 6 | 4 / 6 | 6 / 6 | 6 / 6 | 5 / 8 | 7 / 8 | 3 / 6 | 6 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 23 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
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.
Time frame: 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)
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 10 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 1 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 3 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 3 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 4 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 6 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 6 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 4 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 6 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 4 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 6 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 6 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 5 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 7 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 3 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 6 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE) | 5 Participants |
Primary
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose
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.
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 2 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 1 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 1 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 2 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 1 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 2 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 1 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 1 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 1 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 1 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 3 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 1 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 1 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 1 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 1 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 1 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 1 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 1 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 3 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, <50 bpm | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QTcF Interval, >=500 msec | 1 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | ECG HR, >120 bpm | 1 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, <=80 msec | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | PR Interval, >=200 msec | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, <=80 msec | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose | QRS Duration, >=120 msec | 0 Participants |
Primary
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose
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.
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment. Here, LLN = lower limit of normal; RBC = red blood cell; WBC = white blood cell; ALP = alkaline phosphatase; GGT = Gamma-glutamyl transferase; g/L = gram per liter; mmol/L = millimoles per liter; mg/dL = milligrams per deciliter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 1 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 1 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 1 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Alanine Aminotransferase (ALT) (units per liter [U/L]: >3* upper limit of normal (ULN) | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose | Chemistry, Aspartate Aminotransferase (AST) (U/L): >3*ULN | 0 Participants |
Primary
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose
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.
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Population: The safety analysis set included all participants who were randomized and received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 6 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 3 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 10 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 3 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 4 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 1 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 3 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 3 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 3 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 3 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 1 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 3 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 2 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 2 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 1 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 4 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 5 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 1 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 3 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 5 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 2 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 2 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 1 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 1 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 2 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 1 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 4 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 3 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 5 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 6 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 4 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 1 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 3 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 2 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 4 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 5 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 6 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 3 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 1 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 2 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 1 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 2 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 1 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 2 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 4 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 6 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 4 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 1 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 1 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 4 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 1 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 1 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 4 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 4 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 1 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 6 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 1 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 5 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 4 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 3 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 6 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 1 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 4 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 5 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: <85 mmHg | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: >16 breaths/minute | 5 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: <50 mmHg | 3 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Standing: >120 bpm | 4 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic SBP: Decrease in SBP >=20 mmHg on standing | 3 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic DBP: Decrease in DBP >=10 mmHg on standing | 1 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Respiratory Rate, Semi-Recumbent: <12 breaths/minute | 1 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Standing: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Orthostatic PR: Increase of >30 or HR >120 mmHg on standing | 5 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: <85 mmHg | 2 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Semi-Recumbent: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: <50 mmHg | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, <35.6 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | DBP, Semi-Recumbent: >110 mmHg | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | Temperature, >37.7 Degree Celsius | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | SBP, Standing: >180 mmHg | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: <50 bpm | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose | PR, Semi-Recumbent: >120 bpm | 0 Participants |
Secondary
Part 3: Number of ADA Positive Participants Based on Low or High ADA Titer
The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer \>16 and low ADA titer was defined as participant whose postbaseline ADA titers are all \<=16. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Time frame: Part 3: From the first dose of study drug up to Day 29
Secondary
Part 3: Number of Participants Based on ADA Status (Positive and Negative) in Serum
A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Time frame: Part 3: From the first dose of study drug up to Day 29
Secondary
Part 3, Number of Participants Reporting One or More TEAE Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
A TEAE was defined as an 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. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Time frame: Part 3: From the first dose of study drug until 30 days after last dose (up to Day 37)
Secondary
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
ECG included HR, PR, QT QTcF interval and QRS duration. The MAV criteria for 12-lead ECG parameters included heart rate \<50 bpm, \>120 bpm; PR interval \<=80 msec, \>=200 msec; QTcF interval \>=500 msec or \>=30 msec change from baseline and \>=450 msec; QRS duration \<=80 msec, \>=120 msec. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Time frame: Part 3: From the first dose of study drug up to Day 29
Secondary
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
MAV criteria: 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. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3. Hence, no data collection and assessment were done in Part 3.
Time frame: Part 3: From the first dose of study drug up to Day 29
Secondary
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
Vital signs included systolic and diastolic blood pressure, body temperature, PR, respiratory rate, orthostatic blood pressure and pulse rate assessments. The MAV criteria for vital signs were systolic SBP \< 85 mmHg, \>180 mmHg; DBP \<50 mmHg, \>110 mmHg; body temperature \<35.6 degree Celsius, \>37.7 degree Celsius; PR \<50 bpm, \>120 bpm; respiratory rate \<12 breaths/minute, \>16 breaths/minute; orthostatic hypotension decrease in SBP \>=20 mmHg or a decrease in DBP \>=10 mmHg on standing; orthostatic tachycardia defined as an increase of \>30 bpm or HR \>120 bpm on standing. Sponsor decided not to conduct Part 3 after comprehensive review of available data. No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Time frame: Part 3: From the first dose of study drug up to Day 29
Population: No participants were enrolled in Part 3 of the study. Hence, no data collection and assessment were done in Part 3.
Secondary
Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer
The high ADA titer was defined as participant who has at least 1 post-baseline ADA titer \>16 and low ADA titer was defined as participant whose postbaseline ADA titers are all \<=16. The low or high ADA titer was assessed in ADA positive participants only.
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Population: The immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had the baseline sample and at least 1 postbaseline sample. Here overall number of participants analyzed signifies those participants who had positive ADA status in at least 1 postbaseline assessments.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 3 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 1 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 2 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer High | 0 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of ADA Positive Participants Based on Low or High ADA Titer | ADA Titer Low | 2 Participants |
Secondary
Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum
A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA positive was defined as participants who had confirmed positive ADA status in at least 1 postbaseline assessments. ADA negative was defined as participants who did not have a confirmed negative ADA status in any post-baseline assessment.
Time frame: Parts 1 and 2: From the first dose of study drug up to Day 29
Population: The immunogenicity analysis set included all participants who received at least 1 dose of study treatment and had the baseline sample and at least 1 postbaseline sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 3 Participants |
| Part 1, SRD Cohorts 1 to 11: Pooled Placebo | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 20 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 1, SRD Cohort 1: TAK-510 Dose 1 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 1, SRD Cohort 2: TAK-510 Dose 2 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 3: TAK-510 Dose 3 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 4: TAK-510 Dose 4 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 7 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 1, SRD Cohort 5: TAK-510 Dose 5 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 5 Participants |
| Part 1, SRD Cohort 6: TAK-510 Dose 6 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 7: TAK-510 Dose 7 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 1 Participants |
| Part 1, SRD Cohort 8: TAK-510 Dose 8 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 5 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 2 Participants |
| Part 1, SRD Cohort 9: TAK-510 Dose 9 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 4 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 1, SRD Cohort 10: TAK-510 Dose 10 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 5 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 1, SRD Cohort 11: TAK-510 Dose 11 | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 8 Participants |
| Part 2, MRD 12 to 15 Cohorts: Pooled Placebo | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 2, MRD Cohort 12: Dose 1A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 2, MRD Cohort 13: Dose 2A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 0 Participants |
| Part 2, MRD Cohort 14: Dose 3A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 6 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Negative | 4 Participants |
| Part 2, MRD Cohort 15: Dose 4A | Parts 1 and 2: Number of Participants Based on Antidrug Antibody (ADA) Status (Positive and Negative) in Serum | ADA Positive | 2 Participants |
Other Pre-specified
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 1, CL/F: Apparent Clearance After Extravascular Administration for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 1, T1/2z: Terminal Disposition Phase Half-life for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 1, Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval (Tau) at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 24 hours) post-dose
Other Pre-specified
Part 2, AUCτ: Area Under the Plasma Concentration-time Curve Over a Dosing Interval for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose
Other Pre-specified
Part 2, AUCτss: Area Under the Plasma Concentration-time Curve Over a Dosing Interval at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, CL/F: Apparent Clearance After Extravascular Administration at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, Cmaxss: Maximum Observed Plasma Concentration at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, Ctrough: Observed Plasma Concentration at the End of a Dosing Interval at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, Rac (AUC): Accumulation Ratio Based on AUCτ at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, Rac (Cmax): Accumulation Ratio Based on Cmax at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, T1/2z: Terminal Disposition Phase Half-life at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, Tmaxss: Time to Reach the Maximum Observed Plasma Concentration at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Part 2, Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration at Steady State for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 2, Day 5: pre-dose and at multiple time points (up to 96 hours) post-dose
Other Pre-specified
Parts 1 and 2, Aet1-t2: Amount of Drug Excreted in Urine From Time 1 to Time 2 for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; Part 2, Days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose
Other Pre-specified
Parts 1 and 2, Aet: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Parts 1 and 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose
Other Pre-specified
Parts 1 and 2, CLR: Renal Clearance for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; Part 2, Days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose
Other Pre-specified
Parts 1 and 2, Cmax: Maximum Observed Plasma Concentration for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose; Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose
Other Pre-specified
Parts 1 and 2, fe,t: Fraction of Administered Dose of Drug Excreted From Urine From Time 0 to Time t for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; Part 2, Days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose
Other Pre-specified
Parts 1 and 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-510
Due to confidentiality reasons and chances of exposing the doses for TAK-510, the data for this pharmacokinetic outcome measure was not reported.
Time frame: Part 1, Day 1: pre-dose and at multiple time points (up to 96 hours) post-dose; Part 2, Day 1: pre-dose and at multiple time points (up to 24 hours) post-dose