Alzheimer Disease, Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study was to assess the safety, tolerability, and pharmacokinetic (PK) of TAK-071 when administered as single rising dose (SRD) and multiple rising dose (MRD) orally in healthy participants and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD).
Detailed description
TAK-071 was being tested to find a safe and well-tolerated dose in healthy participants (non-Japanese and Japanese) and participants with MCI or mild AD (non-Japanese). The study enrolled 179 participants. The study consisted of 4 parts: Single-rising dose (SRD) part (Cohorts 1-6, and 18-22), multiple-rising dose (MRD) part (Cohorts 7-15), Cohort 16 with 2-arm parallel design, and Cohort 17 relative bioavailability and food effect 3 period crossover design. Participants in each cohort were randomized to receive treatment with TAK-071 or matching placebo using drug-in-capsule (DIC) in the morning following a minimum fast of 8 hours. In Cohort 16, participants were assigned to 1 of 2 possible treatments, TAK-071 or matching placebo. In Cohort 17, participants were assigned to 1 of 3 treatment sequences (ABC, BCA, or CAB) with treatment A being fasted state and capsule formulation, treatment B being fasted state and tablet formulation, and treatment C being fed state and tablet formulation. In Cohorts 20-22, participants were administered as a single dose of TAK-071 or placebo on Day 1, and a single dose of donepezil or placebo approximately 24 hours later on Day 2. This multi-center trial was conducted in United States. The overall time to participate in this study was approximately 41 days. Participants made multiple visits to the clinic and were also contacted for the follow-up through the telephone.
Interventions
DRUGTAK-071
TAK-071 capsules
DRUGDonepezil
Donepezil over-encapsulated tablet
DRUGTAK-071 Placebo
TAK-071 placebo-matching capsules
Donepezil placebo-matching over-encapsulated tablet
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Man or woman who weighs at least 50 kg and has a body mass index (BMI) from 18.0 to 30.0 kg/m\^2, inclusive, at Screening. Participants should be aged 18 to 55 years, inclusive (nonelderly at the time of informed consent and first study drug dose) for Cohorts 1 to 12, and 17 to 22; 20 to 55 years, inclusive, for Cohorts 13 to 15; and 55 to 90 years, inclusive, for participants in Cohort 16. 2. For Cohorts 13 to 15 only: First-generation Japanese, defined as having been born in Japan of Japanese parents and Japanese grandparents and living no more than 10 years outside of Japan, with no significant change in lifestyle, including diet, while living outside of Japan. 3. Cohort 16 only: Healthy elderly or participants with MCI or mild AD, who must have Mini Mental State Examination (MMSE) score of 18 to 30, inclusive or 18 to 26 inclusive, respectively, and no biomarker data to contradict this diagnosis. Participants with documented diagnosis of MCI or mild AD must be receiving ongoing donepezil therapy (10 mg) in the evening for a minimum of 21 days prior to Check-in (Day -1) or must consent to take donepezil dose titrated to at least 21 days of treatment with 10 mg QD prior to Check-in.
Exclusion criteria
1. Has clinically significant (Cohorts 1 to 15 and 17 to 22) or uncontrolled (Cohort 16) neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (GI), urologic, immunologic, endocrine, or psychiatric disease or other abnormality (other than the disease being studied), which may impact the ability of the participant to participate or potentially confound the study results. 2. Has a history of type 1 diabetes (Cohorts 1 to 22) or type 2 diabetes (Cohorts 1 to 15, 17 to 22) or hemoglobin A1c \>6.5% at Screening. Note: participants with controlled (hemoglobin A1c \<7.0% at Screening) type 2 diabetes in Cohort 16 may participate in the study. 3. Has a risk of suicide or suicidal ideation with intent and plan according to the investigator's clinical judgment (affirmative answer to questions 4 and 5 of the ideation section of the Columbia-Suicide Severity Rating Scale) or has made a suicide attempt in the previous 6 months. 4. Cohort 16 only: Any significant neurologic disease (other than suspected incipient or mild AD), such as Parkinson disease, stroke, transient ischemic attack, multi-infarct dementia, Huntington disease, head trauma with clinically significant cognitive sequelae, or chronic central nervous system infection, per investigator discretion. 5. Has current or recent (within 6 months) GI disease that would be expected to influence the absorption of drugs (ie, a history of malabsorption, any surgical intervention known to impact absorption \[eg, bariatric surgery or bowel resection\], esophageal reflux, peptic ulcer disease, erosive esophagitis, or frequent \[more than once per week\] occurrence of heartburn).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose | — |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Day 1 up to Day 41 | Clinical laboratory tests included serum chemistry, hematology, coagulation and urinalysis. ULN=upper limit of normal range. |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Day 1 up to Day 41 | Vital Sign measurements included systolic blood pressure (SBP), diastolic blood presssure (DBP), pulse, temperature, orthostatic SBP, orthostatic DBP and orthostatic pulse. |
| Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | Day 1 up to Day 41 | A standard 12-lead electrocardiogram (ECG) was performed. The percentage of participants with markedly abnormal ECG findings during the study. |
| Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8] | Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28] | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8] | Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28] | Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | — |
| Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8] | Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28] | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8] | Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28] | Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21] | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8] | Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28] | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1] | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8] | Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28] | Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | — |
| AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose | — |
| Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | Day 1 up to Day 41 | An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs or gets worse after receiving study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose and Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose | — |
| AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese | Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose | — |
| AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | — |
| AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | — |
| Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | — |
| Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | — |
| CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | — |
| CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | — |
| Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
| Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | Pre-dose on Day 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9 | — |
| Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants | Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose | — |
| Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9 | — |
| Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants | Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose | — |
| AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose | — |
| AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Pre-dose on Day 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8, and pre-dose on Day 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9 | — |
| AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | — |
| Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose | — |
| Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9 | — |
| Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | — |
| CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose | — |
| CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 multiple time points (up to 96 hours) post-dose for Cohort 9 | — |
| Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071 | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose Cohort 9 | — |
| CLR: Renal Clearance for TAK-071 MRD Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | — |
| CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071 | Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose | — |
| CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071 | Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose | — |
| CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071 | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | — |
| Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071 | Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose | — |
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | — |
| Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | — |
| AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | — |
| Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071 | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | A linear mixed effect model on the natural log-transformed parameters was performed with day as a fixed effect and participant as a random effect. Ratio is the exponentiated geometric mean value Day 21/Day -1 on the original scale. |
| Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071 | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | A linear mixed effect model on the natural log-transformed parameters was performed with day as a fixed effect and participant as a random effect. Ratio is the exponentiated geometric mean value Day 21/Day -1 on the original scale. |
| AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | — |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 1 investigative site in United States from 05 May 2016 to 08 June 2017.
Pre-assignment details
Healthy participants (non-Japanese and Japanese) and participants with mild cognitive impairment (MCI) or mild Alzheimer disease (AD) (non-Japanese) were enrolled in cohorts: TAK-071 single-rising-dose (SRD), multiple-rising dose (MRD), Food Effect Crossover or in combination with donepezil.
Participants by arm
| Arm | Count |
|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 TAK-071 placebo-matching capsules, orally, once on Day 1 to non-Japanese healthy participants in the single-rising dose (SRD) period. | 16 |
| SRD: Cohort 1: TAK-071 1 mg TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | 6 |
| SRD: Cohort 2: TAK-071 3 mg TAK-071 3 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety, tolerability and pharmacokinetic (PK) data from cohort 1. | 6 |
| SRD: Cohort 3: TAK-071 9 mg TAK-071 9 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK and 12-hour CSF PK data. | 6 |
| SRD: Cohort 4: TAK-071 20 mg TAK-071 20 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on the 24-hour post-dose safety and tolerability data from previous cohort. | 6 |
| SRD: Cohort 5: TAK-071 40 mg TAK-071 40 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 will be based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 4. | 6 |
| SRD: Cohort 6: TAK-071 80 mg TAK-071 80 mg capsules, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 5 | 6 |
| MRD: Placebo Cohorts 7-9 TAK-071 placebo-matching capsule, orally, once on Day 1 to non-Japanese healthy participants in the multiple-rising dose (MRD) period. | 6 |
| MRD: Cohort 7: TAK-071 3 mg TAK-071 3 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability from Cohort 4 and the 24-hour preliminary plasma PK and 12-hour CSF PK data from Cohort 3. | 6 |
| MRD: Cohort 8: TAK-071 9 mg TAK-071 9 mg capsules, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants. Dose of TAK-071 was based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort. | 6 |
| MRD: Cohort 9: TAK-071 15 mg TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to non-Japanese healthy participants. Dose of TAK-071 will be based on safety, tolerability and available PK data arising from the ongoing SRD part and previous MRD cohort. | 6 |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil TAK-071 placebo-matching capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. | 6 |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg TAK-071 3 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 7. | 6 |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg TAK-071 9 mg capsules, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 8. | 6 |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg TAK-071 15 mg capsule, orally, once daily along with donepezil 5 mg, tablets, orally, once daily from Day 1 up to Day 21 to non-Japanese healthy participants who were pre-treated with donepezil 5 mg, tablet, once daily for 3 weeks prior to administration of TAK-071. Dose of TAK-071 was same as the dose used in MRD Cohort 9. | 6 |
| MRD: Placebo Cohorts 13-15 TAK-071 placebo-matching capsule, orally, once on Day 1 to Japanese healthy participants. | 3 |
| MRD: Cohort 13: TAK-071 3 mg TAK-071 3 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 7. | 5 |
| MRD: Cohort 14: TAK-071 9 mg TAK-071 9 mg capsule or matching placebo, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 8. | 5 |
| MRD: Cohort 15: TAK-071 15 mg TAK-071 15 mg capsule, orally, once on Day 1, followed by a washout period of 7 days, then TAK-071 once daily for 21 days to Japanese healthy participants. Dose of TAK-071 was same as the dose used in MRD Cohort 9. | 5 |
| Cohort 16 TAK-071 capsule, orally, once on Day 1 for 21 days, followed by a washout period of 21 days, or placebo matching tablets, orally, once on Day 1 for 21 days. Donepezil was delivered as 5 mg tablet, orally, once followed by 10 mg tablet, orally, once in run-in period. | 0 |
| Bioavailability (BA)/Food Effect: Cohort 17 Sequence ABC A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1, followed by B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 2, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period. | 4 |
| BA/Food Effect: Cohort 17 Sequence BCA B: TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1, followed by C: TAK-071 10 mg tablet, orally, once on Day 1 in the Fed state in Period 2, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period. | 4 |
| BA/Food Effect: Cohort 17 Sequence CAB C: TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1, followed by A: TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 2, followed by B: TAK-20 10 mg tablet, orally, once on Day 1 in the fasted state in Period 3 in non-Japanese healthy participants. There was a 21-day washout after each period. | 4 |
| SRD: Cohort 18: TAK-071 120 mg TAK-071 120 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 6. | 6 |
| SRD: Cohort 19: TAK-071 160 mg TAK-071 160 mg capsule, orally, once on Day 1 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 18. | 6 |
| SRD: TAK-071 Placebo+Donepezil Placebo TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil placebo-matching tablet, orally on Day 2 to non-Japanese healthy participants. | 9 |
| SRD: TAK-071 Placebo+Donepezil TAK-071 placebo-matching capsule, orally, once on Day 1 followed by donepezil 10 mg tablet, orally, on Day 2 to non-Japanese healthy participants. | 9 |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil TAK-071 40 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety, tolerability, and preliminary plasma PK data from Cohort 19. | 5 |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil TAK-071 60 mg capsule, orally, once on Day 1 followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 20. | 6 |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil TAK-071 80 mg capsule, orally, once on Day 1, followed by donepezil 10 mg, tablets, orally, once on Day 2 to non-Japanese healthy participants. Dose of TAK-071 was based on 24-hour safety and tolerability data from Cohort 21. | 6 |
| Total | 177 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Pre-treatment Event/Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Reason Not Specified | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Voluntary Withdrawal | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | MRD: Placebo Cohorts 13-15 | MRD: Placebo Cohorts 7-9 | SRD: Placebo Cohorts 1-6, 18 and 19 | SRD: Cohort 1: TAK-071 1 mg | SRD: Cohort 2: TAK-071 3 mg | SRD: Cohort 3: TAK-071 9 mg | SRD: Cohort 4: TAK-071 20 mg | MRD: Cohort 7: TAK-071 3 mg | MRD: Cohort 8: TAK-071 9 mg | MRD: Cohort 9: TAK-071 15 mg | MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | MRD: Cohort 13: TAK-071 3 mg | MRD: Cohort 14: TAK-071 9 mg | MRD: Cohort 15: TAK-071 15 mg | Bioavailability (BA)/Food Effect: Cohort 17 Sequence ABC | BA/Food Effect: Cohort 17 Sequence BCA | BA/Food Effect: Cohort 17 Sequence CAB | SRD: Cohort 18: TAK-071 120 mg | SRD: Cohort 5: TAK-071 40 mg | SRD: Cohort 19: TAK-071 160 mg | SRD: TAK-071 Placebo+Donepezil Placebo | SRD: TAK-071 Placebo+Donepezil | SRD: Cohort 20: TAK-071 40 mg+Donepezil | SRD: Cohort 21: TAK-071 60 mg+Donepezil | SRD: Cohort 22: TAK-071 80 mg+Donepezil | Total | SRD: Cohort 6: TAK-071 80 mg | Cohort 16 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 3.79 | 37.7 years STANDARD_DEVIATION 6.56 | 33.2 years STANDARD_DEVIATION 6.46 | 34.7 years STANDARD_DEVIATION 4.32 | 32.8 years STANDARD_DEVIATION 9.43 | 39.5 years STANDARD_DEVIATION 11.33 | 41.7 years STANDARD_DEVIATION 9.33 | 33.2 years STANDARD_DEVIATION 7.78 | 31.2 years STANDARD_DEVIATION 8.59 | 39.2 years STANDARD_DEVIATION 6.71 | 38.7 years STANDARD_DEVIATION 6.31 | 36.5 years STANDARD_DEVIATION 6.53 | 35.3 years STANDARD_DEVIATION 7.17 | 36.7 years STANDARD_DEVIATION 9.54 | 38.2 years STANDARD_DEVIATION 10.99 | 34.8 years STANDARD_DEVIATION 6.42 | 36.2 years STANDARD_DEVIATION 8.67 | 32.3 years STANDARD_DEVIATION 7.37 | 38.3 years STANDARD_DEVIATION 8.88 | 30.0 years STANDARD_DEVIATION 2.45 | 31.8 years STANDARD_DEVIATION 10.26 | 36.3 years STANDARD_DEVIATION 8.16 | 31.7 years STANDARD_DEVIATION 6.95 | 38.0 years STANDARD_DEVIATION 9.18 | 36.8 years STANDARD_DEVIATION 9.82 | 38.6 years STANDARD_DEVIATION 13.2 | 32.2 years STANDARD_DEVIATION 6.77 | 35.8 years STANDARD_DEVIATION 9.47 | 36.4 years STANDARD_DEVIATION 9.36 | 29.7 years STANDARD_DEVIATION 8.12 | — |
| Alcohol Classification Current Drinker | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 23 Participants | 0 Participants | — |
| Alcohol Classification Ex-drinker | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Alcohol Classification Never Drunk | 2 Participants | 6 Participants | 12 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 4 Participants | 5 Participants | 6 Participants | 3 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 3 Participants | 6 Participants | 4 Participants | 4 Participants | 8 Participants | 8 Participants | 5 Participants | 6 Participants | 6 Participants | 154 Participants | 6 Participants | — |
| Body Mass Index (BMI) | 23.38 kg/m^2 STANDARD_DEVIATION 4.074 | 26.04 kg/m^2 STANDARD_DEVIATION 2.596 | 26.18 kg/m^2 STANDARD_DEVIATION 2.349 | 24.99 kg/m^2 STANDARD_DEVIATION 2.827 | 23.82 kg/m^2 STANDARD_DEVIATION 3.09 | 26.50 kg/m^2 STANDARD_DEVIATION 2.018 | 27.13 kg/m^2 STANDARD_DEVIATION 2.766 | 26.30 kg/m^2 STANDARD_DEVIATION 2.966 | 25.71 kg/m^2 STANDARD_DEVIATION 3.327 | 24.58 kg/m^2 STANDARD_DEVIATION 3.503 | 26.59 kg/m^2 STANDARD_DEVIATION 2.428 | 24.46 kg/m^2 STANDARD_DEVIATION 2.344 | 24.52 kg/m^2 STANDARD_DEVIATION 2.267 | 27.10 kg/m^2 STANDARD_DEVIATION 2.066 | 23.69 kg/m^2 STANDARD_DEVIATION 1.113 | 22.56 kg/m^2 STANDARD_DEVIATION 3.615 | 23.45 kg/m^2 STANDARD_DEVIATION 3.032 | 24.95 kg/m^2 STANDARD_DEVIATION 1.237 | 27.06 kg/m^2 STANDARD_DEVIATION 2.221 | 24.66 kg/m^2 STANDARD_DEVIATION 3.873 | 26.19 kg/m^2 STANDARD_DEVIATION 3.611 | 26.65 kg/m^2 STANDARD_DEVIATION 1.895 | 25.60 kg/m^2 STANDARD_DEVIATION 3.265 | 25.21 kg/m^2 STANDARD_DEVIATION 2.721 | 25.66 kg/m^2 STANDARD_DEVIATION 2.078 | 27.36 kg/m^2 STANDARD_DEVIATION 1.767 | 23.73 kg/m^2 STANDARD_DEVIATION 2.388 | 24.65 kg/m^2 STANDARD_DEVIATION 1.432 | 25.30 kg/m^2 STANDARD_DEVIATION 2.351 | 24.65 kg/m^2 STANDARD_DEVIATION 1.895 | — |
| Female Reproductive Status Female of Childbearing Potential | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Female Reproductive Status N/A (Subject is Male) | 3 Participants | 6 Participants | 15 Participants | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 8 Participants | 4 Participants | 6 Participants | 4 Participants | 166 Participants | 6 Participants | — |
| Female Reproductive Status Postmenopausal | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 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 | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 6 Participants | 0 Participants | — |
| Female Reproductive Status Surgically Sterile | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 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 | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 5 Participants | 0 Participants | — |
| Height | 172.3 cm STANDARD_DEVIATION 2.08 | 173.0 cm STANDARD_DEVIATION 9.63 | 175.8 cm STANDARD_DEVIATION 6.31 | 169.0 cm STANDARD_DEVIATION 5.97 | 175.0 cm STANDARD_DEVIATION 6.99 | 179.3 cm STANDARD_DEVIATION 8.14 | 172.3 cm STANDARD_DEVIATION 6.89 | 178.8 cm STANDARD_DEVIATION 6.46 | 172.8 cm STANDARD_DEVIATION 5.12 | 174.7 cm STANDARD_DEVIATION 6.89 | 175.3 cm STANDARD_DEVIATION 6.53 | 177.0 cm STANDARD_DEVIATION 8.2 | 176.2 cm STANDARD_DEVIATION 4.54 | 168.0 cm STANDARD_DEVIATION 8.72 | 171.2 cm STANDARD_DEVIATION 8.96 | 172.8 cm STANDARD_DEVIATION 6.1 | 178.2 cm STANDARD_DEVIATION 7.33 | 178.8 cm STANDARD_DEVIATION 5.06 | 175.8 cm STANDARD_DEVIATION 8.42 | 175.3 cm STANDARD_DEVIATION 5.8 | 173.0 cm STANDARD_DEVIATION 4.77 | 175.8 cm STANDARD_DEVIATION 7.31 | 174.8 cm STANDARD_DEVIATION 5.56 | 175.2 cm STANDARD_DEVIATION 13.07 | 173.9 cm STANDARD_DEVIATION 7.61 | 178.4 cm STANDARD_DEVIATION 11.28 | 174.7 cm STANDARD_DEVIATION 5.47 | 170.8 cm STANDARD_DEVIATION 10.03 | 174.5 cm STANDARD_DEVIATION 9.64 | 179.8 cm STANDARD_DEVIATION 7.7 | — |
| Race/Ethnicity, Customized 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 | 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/Ethnicity, Customized Asian | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 5 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 27 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 2 Participants | 5 Participants | 1 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 4 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 1 Participants | 44 Participants | 2 Participants | — |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants | 2 Participants | 1 Participants | 1 Participants | 3 Participants | 41 Participants | 3 Participants | — |
| Race/Ethnicity, Customized Multiracial | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 8 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 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 | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | — |
| Race/Ethnicity, Customized Not Hispanic or Latino | 3 Participants | 5 Participants | 14 Participants | 3 Participants | 6 Participants | 5 Participants | 4 Participants | 6 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 6 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 4 Participants | 4 Participants | 5 Participants | 4 Participants | 7 Participants | 4 Participants | 5 Participants | 3 Participants | 136 Participants | 3 Participants | — |
| Race/Ethnicity, Customized White | 0 Participants | 4 Participants | 8 Participants | 3 Participants | 2 Participants | 3 Participants | 4 Participants | 2 Participants | 4 Participants | 5 Participants | 1 Participants | 4 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 5 Participants | 5 Participants | 3 Participants | 6 Participants | 6 Participants | 3 Participants | 3 Participants | 5 Participants | 94 Participants | 3 Participants | — |
| Region of Enrollment United States | 3 Participants | 6 Participants | 16 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 9 Participants | 9 Participants | 5 Participants | 6 Participants | 6 Participants | 177 Participants | 6 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 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 | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 11 Participants | 0 Participants | — |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 15 Participants | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 5 Participants | 5 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 8 Participants | 4 Participants | 6 Participants | 4 Participants | 166 Participants | 6 Participants | — |
| Smoking Classification Current Smoker | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Smoking Classification Ex-smoker | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 23 Participants | 0 Participants | — |
| Smoking Classification Never Smoked | 2 Participants | 5 Participants | 15 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 3 Participants | 5 Participants | 6 Participants | 5 Participants | 3 Participants | 5 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 5 Participants | 4 Participants | 8 Participants | 8 Participants | 3 Participants | 6 Participants | 6 Participants | 154 Participants | 6 Participants | — |
| Weight | 69.63 kg STANDARD_DEVIATION 13.668 | 78.05 kg STANDARD_DEVIATION 10.936 | 80.77 kg STANDARD_DEVIATION 7.563 | 71.80 kg STANDARD_DEVIATION 11.927 | 73.25 kg STANDARD_DEVIATION 12.314 | 85.35 kg STANDARD_DEVIATION 9.712 | 80.35 kg STANDARD_DEVIATION 7.076 | 84.22 kg STANDARD_DEVIATION 11.284 | 76.73 kg STANDARD_DEVIATION 10.094 | 75.33 kg STANDARD_DEVIATION 14.062 | 81.93 kg STANDARD_DEVIATION 10.508 | 76.55 kg STANDARD_DEVIATION 8.147 | 76.23 kg STANDARD_DEVIATION 9.066 | 76.72 kg STANDARD_DEVIATION 9.972 | 69.52 kg STANDARD_DEVIATION 7.253 | 67.72 kg STANDARD_DEVIATION 14.487 | 74.72 kg STANDARD_DEVIATION 12.583 | 79.73 kg STANDARD_DEVIATION 5.421 | 83.85 kg STANDARD_DEVIATION 11.356 | 75.53 kg STANDARD_DEVIATION 10.529 | 78.63 kg STANDARD_DEVIATION 12.98 | 82.58 kg STANDARD_DEVIATION 9.87 | 78.42 kg STANDARD_DEVIATION 11.553 | 77.58 kg STANDARD_DEVIATION 12.727 | 77.66 kg STANDARD_DEVIATION 8.549 | 87.28 kg STANDARD_DEVIATION 11.637 | 72.25 kg STANDARD_DEVIATION 6.339 | 70.78 kg STANDARD_DEVIATION 10.039 | 77.09 kg STANDARD_DEVIATION 10.857 | 80.00 kg STANDARD_DEVIATION 10.942 | — |
| Xanthine/Caffeine Consumption No | 0 Participants | 6 Participants | 14 Participants | 6 Participants | 5 Participants | 4 Participants | 3 Participants | 6 Participants | 6 Participants | 3 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 5 Participants | 4 Participants | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 5 Participants | 3 Participants | 3 Participants | 7 Participants | 4 Participants | 5 Participants | 6 Participants | 137 Participants | 6 Participants | — |
| Xanthine/Caffeine Consumption Yes | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 6 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 40 Participants | 0 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 | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 0 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 5 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 4 / 16 | 2 / 6 | 0 / 6 | 4 / 6 | 2 / 6 | 0 / 6 | 1 / 6 | 3 / 6 | 1 / 6 | 1 / 6 | 3 / 6 | 2 / 6 | 2 / 6 | 3 / 6 | 3 / 6 | 2 / 3 | 2 / 5 | 2 / 5 | 3 / 5 | 0 / 0 | 2 / 12 | 1 / 12 | 1 / 12 | 0 / 6 | 2 / 6 | 4 / 9 | 5 / 9 | 4 / 5 | 6 / 6 | 5 / 6 |
| serious Total, serious adverse events | 0 / 16 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 0 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 5 | 0 / 6 | 0 / 6 |
Outcome results
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1] | 1485 h*ng/mL | Standard Deviation 271.95 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1] | 4201 h*ng/mL | Standard Deviation 822.67 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 1] | 5581 h*ng/mL | Standard Deviation 1141.6 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28]
Time frame: Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28] | 4439 h*ng/mL | Standard Deviation 1135.6 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28] | 13450 h*ng/mL | Standard Deviation 3024.3 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 28] | 17120 h*ng/mL | Standard Deviation 8088.8 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8]
Time frame: Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8] | 1529 h*ng/mL | Standard Deviation 344 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8] | 4634 h*ng/mL | Standard Deviation 787.02 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Japanese Participants [Day 8] | 6110 h*ng/mL | Standard Deviation 1217.2 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1] | 5332 h*ng/mL | Standard Deviation 1688.9 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1] | 1442 h*ng/mL | Standard Deviation 251.62 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1] | 3636 h*ng/mL | Standard Deviation 286.83 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 1] | 5832 h*ng/mL | Standard Deviation 921.06 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]
Time frame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21] | 4783 h*ng/mL | Standard Deviation 1258 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21] | 12520 h*ng/mL | Standard Deviation 2132.7 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21]
Time frame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21] | 4467 h*ng/mL | Standard Deviation 1461.6 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21] | 13570 h*ng/mL | Standard Deviation 1647 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 21] | 19210 h*ng/mL | Standard Deviation 4669.4 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28]
Time frame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 28] | 19920 h*ng/mL | Standard Deviation 4563.7 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8]
Time frame: Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 MRD Non-Japanese Participants [Day 8] | 5831 h*ng/mL | Standard Deviation 998.5 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | 1347 h*ng/mL | Standard Deviation 302.98 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | 3550 h*ng/mL | Standard Deviation 765.01 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 459.3 h*ng/mL | Standard Deviation 111.88 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 1197 h*ng/mL | Standard Deviation 92.81 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 3257 h*ng/mL | Standard Deviation 634.89 |
| SRD: Cohort 3: TAK-071 9 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 6383 h*ng/mL | Standard Deviation 1162.4 |
| SRD: Cohort 4: TAK-071 20 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 8905 h*ng/mL | Standard Deviation 4529.9 |
| SRD: Cohort 5: TAK-071 40 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 16300 h*ng/mL | Standard Deviation 3468.9 |
| SRD: Cohort 6: TAK-071 80 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 22350 h*ng/mL | Standard Deviation 7203.2 |
| MRD: Placebo Cohorts 7-9 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 25660 h*ng/mL | Standard Deviation 8297.7 |
Primary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 18370 h*ng/mL | Standard Deviation 2361.9 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 12810 h*ng/mL | Standard Deviation 2177.9 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 9440 h*ng/mL | Standard Deviation 1353.7 |
Primary
AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 1651 h*ng/mL | Standard Deviation 644.79 |
| SRD: Cohort 1: TAK-071 1 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 5070 h*ng/mL | Standard Deviation 3802 |
| SRD: Cohort 2: TAK-071 3 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 15640 h*ng/mL | Standard Deviation 5944.7 |
| SRD: Cohort 3: TAK-071 9 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 30980 h*ng/mL | Standard Deviation 5932.8 |
| SRD: Cohort 4: TAK-071 20 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 49550 h*ng/mL | Standard Deviation 33766 |
| SRD: Cohort 5: TAK-071 40 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 106000 h*ng/mL | Standard Deviation 19610 |
| SRD: Cohort 6: TAK-071 80 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 132700 h*ng/mL | Standard Deviation 46773 |
| MRD: Placebo Cohorts 7-9 | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants | 162100 h*ng/mL | Standard Deviation 69191 |
Primary
AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil
Time frame: Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | 97640 h*ng/mL | Standard Deviation 22123 |
| SRD: Cohort 1: TAK-071 1 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | 48750 h*ng/mL | Standard Deviation 12598 |
| SRD: Cohort 2: TAK-071 3 mg | AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity, Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | 46370 h*ng/mL | Standard Deviation 6094.8 |
Primary
AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect
Time frame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect | 16010 h*ng/mL | Standard Deviation 4812 |
| SRD: Cohort 1: TAK-071 1 mg | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect | 15190 h*ng/mL | Standard Deviation 4576.6 |
| SRD: Cohort 2: TAK-071 3 mg | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect | 16610 h*ng/mL | Standard Deviation 5003.1 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1] | 78.98 ng/mL | Standard Deviation 10.736 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1] | 208.4 ng/mL | Standard Deviation 47.773 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1] | 278.0 ng/mL | Standard Deviation 63.828 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28]
Time frame: Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28] | 235.6 ng/mL | Standard Deviation 49.242 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28] | 680.2 ng/mL | Standard Deviation 181.99 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28] | 895.2 ng/mL | Standard Deviation 420.14 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8]
Time frame: Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8] | 81.16 ng/mL | Standard Deviation 17.379 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8] | 235.4 ng/mL | Standard Deviation 37.74 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8] | 329.6 ng/mL | Standard Deviation 99.889 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1] | 79.12 ng/mL | Standard Deviation 12.954 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1] | 194.2 ng/mL | Standard Deviation 17.325 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1] | 303.7 ng/mL | Standard Deviation 32.371 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1] | 264.8 ng/mL | Standard Deviation 70.516 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]
Time frame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | 244.5 ng/mL | Standard Deviation 66.163 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | 646.5 ng/mL | Standard Deviation 95.032 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21]
Time frame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | 232.8 ng/mL | Standard Deviation 69.277 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | 678.0 ng/mL | Standard Deviation 67.62 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | 970.7 ng/mL | Standard Deviation 228.98 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28]
Time frame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28] | 936.4 ng/mL | Standard Deviation 173.98 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8]
Time frame: Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8] | 294.2 ng/mL | Standard Deviation 57.007 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | 74.33 ng/mL | Standard Deviation 18.186 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | 196.2 ng/mL | Standard Deviation 54.668 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect
Time frame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect | 219.7 ng/mL | Standard Deviation 46.986 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect | 251.0 ng/mL | Standard Deviation 41.946 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect | 242.5 ng/mL | Standard Deviation 41.513 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 25.65 ng/mL | Standard Deviation 5.8589 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 65.82 ng/mL | Standard Deviation 5.4268 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 162.2 ng/mL | Standard Deviation 36.548 |
| SRD: Cohort 3: TAK-071 9 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 328.0 ng/mL | Standard Deviation 72.2 |
| SRD: Cohort 4: TAK-071 20 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 485.7 ng/mL | Standard Deviation 240.47 |
| SRD: Cohort 5: TAK-071 40 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 901.7 ng/mL | Standard Deviation 210.05 |
| SRD: Cohort 6: TAK-071 80 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 1292 ng/mL | Standard Deviation 315.3 |
| MRD: Placebo Cohorts 7-9 | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 1387 ng/mL | Standard Deviation 312.13 |
Primary
Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 1110 ng/mL | Standard Deviation 85.44 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 725.8 ng/mL | Standard Deviation 186.03 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 532.2 ng/mL | Standard Deviation 28.508 |
Primary
Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs or gets worse after receiving study drug.
Time frame: Day 1 up to Day 41
Population: Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 25.0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 66.7 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 50.0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 50.0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 50.0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 50.0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 66.7 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 40.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 40.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 60.0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 16.7 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 8.3 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 33.3 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 44.4 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 55.6 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 80.0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 100 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE) | 83.3 percentage of participants |
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose
A standard 12-lead electrocardiogram (ECG) was performed. The percentage of participants with markedly abnormal ECG findings during the study.
Time frame: Day 1 up to Day 41
Population: SAS included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 31.3 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 37.5 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 12.5 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 18.8 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 16.7 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 16.7 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 16.7 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 33.3 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 33.3 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 16.7 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 16.7 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 33.3 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 50.0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 16.7 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 33.3 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 16.7 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 50.0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 16.7 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 16.7 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 50.0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 33.3 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 66.7 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 66.7 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 20.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 20.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 40.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 40.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 40.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 40.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 40.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 40.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 16.7 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 33.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 58.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 41.7 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 16.7 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 25.0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 25.0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 66.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 50.0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 44.4 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 22.2 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 11.1 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 20.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 60.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 20.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 20.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 40.0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 33.3 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, >=1440 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean Heart Rate (HR), <50 beats/min | 50.0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QT Interval, Aggregate, >=460 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, <=80 msec | 16.7 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, >=200 msec | 16.7 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | ECG Mean HR, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate ≥500 OR ≥30 and ≥450 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | PR Interval, Aggregate, <=80 millisecond (msec) | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcF Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QTcB Interval, Aggregate, <=50 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | RR Interval, Aggregate, <=600 msec | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for 12-lead Electrocardiogram (ECG) Parameters at Least Once Post-dose | QRS Duration, Aggregate, >=180 msec | 0 percentage of participants |
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose
Clinical laboratory tests included serum chemistry, hematology, coagulation and urinalysis. ULN=upper limit of normal range.
Time frame: Day 1 up to Day 41
Population: SAS included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 6.3 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 16.7 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 16.7 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 16.7 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Aspartate Aminotransferase (>3*ULN) | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Bilirubin (>2.0 mg/dL, >34.2 umol/L) | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Creatine Kinase (>5*ULN) | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Prothrombin Intl. Normalized Ratio (>1.5*ULN) | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Post-dose | Blood Urea Nitrogen (>30 mg/dL, >10.7 mmol/L) | 0 percentage of participants |
Primary
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose
Vital Sign measurements included systolic blood pressure (SBP), diastolic blood presssure (DBP), pulse, temperature, orthostatic SBP, orthostatic DBP and orthostatic pulse.
Time frame: Day 1 up to Day 41
Population: SAS included all randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 75.0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 25.0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 6.3 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 75.0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 6.3 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 12.5 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 6.3 percentage of participants |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 6.3 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 33.3 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 1: TAK-071 1 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 16.7 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 2: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 3: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 16.7 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 33.3 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 4: TAK-071 20 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 16.7 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 5: TAK-071 40 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 16.7 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 33.3 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 16.7 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 33.3 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 6: TAK-071 80 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 66.7 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 33.3 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 66.7 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 50.0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 16.7 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 16.7 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 7-9 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 16.7 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 16.7 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 16.7 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 7: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 33.3 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 33.3 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 16.7 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 33.3 percentage of participants |
| MRD: Cohort 8: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 16.7 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 9: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 16.7 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 16.7 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 16.7 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: TAK-071 Placebo Cohorts 10-12+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 50.0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 33.3 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 33.3 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 33.3 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 33.3 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 50.0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 16.7 percentage of participants |
| MRD: Cohort 10: TAK-071 3 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 16.7 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 50.0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 33.3 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 16.7 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 33.3 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 16.7 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 16.7 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 50.0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 50.0 percentage of participants |
| MRD: Cohort 11: TAK-071 9 mg + Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 50.0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 33.3 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 16.7 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 12: TAK-071 15 mg+Donepezil 5 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 33.3 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 66.7 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Placebo Cohorts 13-15 | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 60.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 20.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 20.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 40.0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 13: TAK-071 3 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 40.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 40.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 40.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 20.0 percentage of participants |
| MRD: Cohort 14: TAK-071 9 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 40.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 40.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 60.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 60.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 40.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 20.0 percentage of participants |
| MRD: Cohort 15: TAK-071 15 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 16.7 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 25.0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 33.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 8.3 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 16.7 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 41.7 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen B | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 25.0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 8.3 percentage of participants |
| BA/Food Effect: Cohort 17 Regimen C | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 33.3 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 66.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 18: TAK-071 120 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 16.7 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 16.7 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 19: TAK-071 160 mg | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 44.4 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 22.2 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 88.9 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 88.9 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil Placebo | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 11.1 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 22.2 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: TAK-071 Placebo+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 20.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 40.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 40.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 20.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 40.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 20.0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 20: TAK-071 40 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 40.0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 33.3 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 21: TAK-071 60 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 1 min Standing-Supine >10 bpm | 100 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Systolic Blood Pressure (SBP), Supine, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, <50 beats/min (bpm) | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 1 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 3 min Standing-Supine, <=-20 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 minutes (min) Supine, <85 mmHg, | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, >37.7 C | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 5 min Supine, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, Supine, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic SBP, 1 min Standing-Supine, <=-20 mmHg | 16.7 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Temperature, <35.6 Celsius (C) | 16.7 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, >120 beats/min | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 5 min Supine, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 1 min Standing, <85 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 3 min Standing, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | DBP, 1 min Standing, >110 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic DBP, 3 min Standing-Supine, <=-10 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | SBP, 3 min Standing, >180 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 1 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 5 min Supine, <50 beats/min | 16.7 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Diastolic Blood Pressure (DBP), Supine, <50 mmHg | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Pulse, 3 min Standing, <50 beats/min | 0 percentage of participants |
| SRD: Cohort 22: TAK-071 80 mg+Donepezil | Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose | Orthostatic Pulse, 3 min Standing-Supine >10 bpm | 100 percentage of participants |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1] | 4.000 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1] | 6.000 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1] | 12.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28]
Time frame: Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28] | 4.000 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28] | 3.000 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28] | 3.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8]
Time frame: Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8] | 4.000 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8] | 6.000 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8] | 8.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1] | 24.058 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1] | 3.508 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1] | 4.992 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1] | 7.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]
Time frame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | 2.500 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | 4.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21]
Time frame: Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | 3.500 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | 3.008 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | 3.500 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28]
Time frame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28] | 3.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8]
Time frame: Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8] | 11.017 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1]
Time frame: Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | 2.500 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | 7.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect
Time frame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect | 4.983 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect | 2.000 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect | 6.000 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: Pharmacokinetic (PK) set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 1.750 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 4.017 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 10.975 hours |
| SRD: Cohort 3: TAK-071 9 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 8.000 hours |
| SRD: Cohort 4: TAK-071 20 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 9.933 hours |
| SRD: Cohort 5: TAK-071 40 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 24.033 hours |
| SRD: Cohort 6: TAK-071 80 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 22.050 hours |
| MRD: Placebo Cohorts 7-9 | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | 24.058 hours |
Primary
Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 26.000 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 26.000 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 30.000 hours |
Secondary
Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants
Time frame: Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants | 2.973 Ratio | Standard Deviation 0.38747 |
| SRD: Cohort 1: TAK-071 1 mg | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants | 3.241 Ratio | Standard Deviation 0.56613 |
| SRD: Cohort 2: TAK-071 3 mg | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants | 3.096 Ratio | Standard Deviation 1.4212 |
Secondary
Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Day 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | 3.568 Ratio | Standard Deviation 0.71765 |
| SRD: Cohort 1: TAK-071 1 mg | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | 3.713 Ratio | Standard Deviation 1.1916 |
| SRD: Cohort 2: TAK-071 3 mg | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | 3.778 Ratio | Standard Deviation 1.2626 |
Secondary
Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | 3.099 Ratio | Standard Deviation 0.7513 |
| SRD: Cohort 1: TAK-071 1 mg | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | 3.749 Ratio | Standard Deviation 0.55862 |
| SRD: Cohort 2: TAK-071 3 mg | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | 3.350 Ratio | Standard Deviation 0.9271 |
Secondary
Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants
Time frame: Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants | 2.960 Ratio | Standard Deviation 0.2618 |
| SRD: Cohort 1: TAK-071 1 mg | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants | 3.327 Ratio | Standard Deviation 0.74832 |
| SRD: Cohort 2: TAK-071 3 mg | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants | 3.285 Ratio | Standard Deviation 1.5406 |
Secondary
Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | 2.929 Ratio | Standard Deviation 0.55096 |
| SRD: Cohort 1: TAK-071 1 mg | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | 3.527 Ratio | Standard Deviation 0.57233 |
| SRD: Cohort 2: TAK-071 3 mg | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | 3.257 Ratio | Standard Deviation 0.95527 |
Secondary
Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose for Cohorts 7 and 8 and Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose for Cohort 9
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | 3.297 Ratio | Standard Deviation 0.59164 |
| SRD: Cohort 1: TAK-071 1 mg | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | 3.578 Ratio | Standard Deviation 1.2955 |
| SRD: Cohort 2: TAK-071 3 mg | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | 3.541 Ratio | Standard Deviation 0.86317 |
Secondary
AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 1 | 0.003436 mg | Standard Deviation 0.0031125 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 28 | 0.01202 mg | Standard Deviation 0.01048 |
| SRD: Cohort 1: TAK-071 1 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 1 | 0.02083 mg | Standard Deviation 0.0094853 |
| SRD: Cohort 1: TAK-071 1 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 28 | 0.03394 mg | Standard Deviation 0.022682 |
| SRD: Cohort 2: TAK-071 3 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 1 | 0.03224 mg | Standard Deviation 0.023202 |
| SRD: Cohort 2: TAK-071 3 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 28 | 0.06482 mg | Standard Deviation 0.062816 |
Secondary
AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8, and pre-dose on Day 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.001501 mg | Standard Deviation 0.0017987 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 21 | 0.009066 mg | Standard Deviation 0.0042349 |
| SRD: Cohort 1: TAK-071 1 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.005973 mg | Standard Deviation 0.0034636 |
| SRD: Cohort 1: TAK-071 1 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 21 | 0.02393 mg | Standard Deviation 0.014412 |
| SRD: Cohort 2: TAK-071 3 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.04929 mg | Standard Deviation 0.019263 |
| SRD: Cohort 2: TAK-071 3 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 28 | 0.1119 mg | Standard Deviation 0.079021 |
Secondary
AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Measurable TAK-071 was not detected in urine for Cohort 1 (TAK-071 1 mg). Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.001731 mg | Standard Deviation 0.0015806 |
| SRD: Cohort 1: TAK-071 1 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.01632 mg | Standard Deviation 0.0062545 |
| SRD: Cohort 2: TAK-071 3 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.05753 mg | Standard Deviation 0.023868 |
| SRD: Cohort 3: TAK-071 9 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.08559 mg | Standard Deviation 0.052157 |
| SRD: Cohort 4: TAK-071 20 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.09052 mg | Standard Deviation 0.044805 |
| SRD: Cohort 5: TAK-071 40 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.1652 mg | Standard Deviation 0.097242 |
| SRD: Cohort 6: TAK-071 80 mg | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.1505 mg | Standard Deviation 0.10905 |
Secondary
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil
Time frame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | Day -1 | 410.1 h*ng/mL | Standard Deviation 79.22 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | Day 21 | 472.5 h*ng/mL | Standard Deviation 62.377 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | Day -1 | 543.8 h*ng/mL | Standard Deviation 113.62 |
| SRD: Cohort 1: TAK-071 1 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | Day 21 | 567.2 h*ng/mL | Standard Deviation 135.33 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | Day -1 | 399.5 h*ng/mL | Standard Deviation 96.519 |
| SRD: Cohort 2: TAK-071 3 mg | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | Day 21 | 430.5 h*ng/mL | Standard Deviation 111.93 |
Secondary
AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants
Time frame: Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose and Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | Day 1 | 3773 h*ng/mL | Standard Deviation 968.76 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | Day 8 | 1529 h*ng/mL | Standard Deviation 344 |
| SRD: Cohort 1: TAK-071 1 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | Day 1 | 11930 h*ng/mL | Standard Deviation 2764.4 |
| SRD: Cohort 1: TAK-071 1 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | Day 8 | 4634 h*ng/mL | Standard Deviation 787.02 |
| SRD: Cohort 2: TAK-071 3 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | Day 1 | 15790 h*ng/mL | Standard Deviation 3273.2 |
| SRD: Cohort 2: TAK-071 3 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | Day 8 | 6110 h*ng/mL | Standard Deviation 1217.2 |
Secondary
AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese
Time frame: Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese | 1442 h*ng/mL | Standard Deviation 251.62 |
| SRD: Cohort 1: TAK-071 1 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese | 3636 h*ng/mL | Standard Deviation 286.83 |
| SRD: Cohort 2: TAK-071 3 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese | 5832 h*ng/mL | Standard Deviation 921.06 |
Secondary
AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and multiple timepoints (up to 24 hrs) post-dose for Cohorts 7 and 8 and Pre-dose on Day 1 and multiple timepoints (up to 96 hrs) post-dose for Cohort 9
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 1347 h*ng/mL | Standard Deviation 302.98 |
| SRD: Cohort 1: TAK-071 1 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 3550 h*ng/mL | Standard Deviation 765.01 |
| SRD: Cohort 2: TAK-071 3 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 16880 h*ng/mL | Standard Deviation 4514.9 |
Secondary
AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 1220 h*ng/mL | Standard Deviation 397.35 |
| SRD: Cohort 1: TAK-071 1 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 3945 h*ng/mL | Standard Deviation 1784.9 |
| SRD: Cohort 2: TAK-071 3 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 12450 h*ng/mL | Standard Deviation 2466.5 |
| SRD: Cohort 3: TAK-071 9 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 26010 h*ng/mL | Standard Deviation 3656.6 |
| SRD: Cohort 4: TAK-071 20 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 40240 h*ng/mL | Standard Deviation 23644 |
| SRD: Cohort 5: TAK-071 40 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 90350 h*ng/mL | Standard Deviation 13944 |
| SRD: Cohort 6: TAK-071 80 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 111700 h*ng/mL | Standard Deviation 31926 |
| MRD: Placebo Cohorts 7-9 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese Participants | 133000 h*ng/mL | Standard Deviation 45126 |
Secondary
AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect
Time frame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect | 14210 h*ng/mL | Standard Deviation 3392.5 |
| SRD: Cohort 1: TAK-071 1 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect | 13260 h*ng/mL | Standard Deviation 2983.9 |
| SRD: Cohort 2: TAK-071 3 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 Relative Bioavailability and Food Effect | 14610 h*ng/mL | Standard Deviation 3324.3 |
Secondary
AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
Time frame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 85650 h*ng/mL | Standard Deviation 13013 |
| SRD: Cohort 1: TAK-071 1 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 45970 h*ng/mL | Standard Deviation 10798 |
| SRD: Cohort 2: TAK-071 3 mg | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 41070 h*ng/mL | Standard Deviation 4387.9 |
Secondary
CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect
Time frame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | 0.6925 L/h | Standard Deviation 0.27468 |
| SRD: Cohort 1: TAK-071 1 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | 0.7232 L/h | Standard Deviation 0.26191 |
| SRD: Cohort 2: TAK-071 3 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | 0.6663 L/h | Standard Deviation 0.25695 |
Secondary
CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 0.7222 L/h | Standard Deviation 0.3613 |
| SRD: Cohort 1: TAK-071 1 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 0.7998 L/h | Standard Deviation 0.36546 |
| SRD: Cohort 2: TAK-071 3 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 0.6494 L/h | Standard Deviation 0.24348 |
| SRD: Cohort 3: TAK-071 9 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 0.6644 L/h | Standard Deviation 0.12027 |
| SRD: Cohort 4: TAK-071 20 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 3.844 L/h | Standard Deviation 7.3558 |
| SRD: Cohort 5: TAK-071 40 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 0.7762 L/h | Standard Deviation 0.13868 |
| SRD: Cohort 6: TAK-071 80 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 1.008 L/h | Standard Deviation 0.36826 |
| MRD: Placebo Cohorts 7-9 | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 1.141 L/h | Standard Deviation 0.45838 |
Secondary
CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 0.8453 L/h | Standard Deviation 0.17228 |
| SRD: Cohort 1: TAK-071 1 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 1.304 L/h | Standard Deviation 0.34484 |
| SRD: Cohort 2: TAK-071 3 mg | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 0.8742 L/h | Standard Deviation 0.11009 |
Secondary
CLR: Renal Clearance for TAK-071 MRD Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CLR: Renal Clearance for TAK-071 MRD Japanese Participants | Day 1 | 0.0008641 L/h | Standard Deviation 0.00063849 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | CLR: Renal Clearance for TAK-071 MRD Japanese Participants | Day 28 | 0.002494 L/h | Standard Deviation 0.0014594 |
| SRD: Cohort 1: TAK-071 1 mg | CLR: Renal Clearance for TAK-071 MRD Japanese Participants | Day 1 | 0.001783 L/h | Standard Deviation 0.00090441 |
| SRD: Cohort 1: TAK-071 1 mg | CLR: Renal Clearance for TAK-071 MRD Japanese Participants | Day 28 | 0.002680 L/h | Standard Deviation 0.0019001 |
| SRD: Cohort 2: TAK-071 3 mg | CLR: Renal Clearance for TAK-071 MRD Japanese Participants | Day 1 | 0.002093 L/h | Standard Deviation 0.0016105 |
| SRD: Cohort 2: TAK-071 3 mg | CLR: Renal Clearance for TAK-071 MRD Japanese Participants | Day 28 | 0.003426 L/h | Standard Deviation 0.0021244 |
Secondary
CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 multiple time points (up to 96 hours) post-dose for Cohort 9
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.001133 L/h | Standard Deviation 0.0015553 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | Day 21 | 0.001937 L/h | Standard Deviation 0.00099073 |
| SRD: Cohort 1: TAK-071 1 mg | CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.001686 L/h | Standard Deviation 0.00092928 |
| SRD: Cohort 1: TAK-071 1 mg | CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | Day 21 | 0.001991 L/h | Standard Deviation 0.0012947 |
| SRD: Cohort 2: TAK-071 3 mg | CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.003163 L/h | Standard Deviation 0.0016448 |
| SRD: Cohort 2: TAK-071 3 mg | CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | Day 28 | 0.005431 L/h | Standard Deviation 0.0032772 |
Secondary
CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Measurable TAK-071 was not detected in urine for Cohort 1 (TAK-071 1 mg). Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | 0.0006354 L/h | Standard Deviation 0.00072647 |
| SRD: Cohort 1: TAK-071 1 mg | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | 0.001668 L/h | Standard Deviation 0.00058267 |
| SRD: Cohort 2: TAK-071 3 mg | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | 0.002775 L/h | Standard Deviation 0.00098052 |
| SRD: Cohort 3: TAK-071 9 mg | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | 0.002453 L/h | Standard Deviation 0.0015795 |
| SRD: Cohort 4: TAK-071 20 mg | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | 0.001425 L/h | Standard Deviation 0.00071797 |
| SRD: Cohort 5: TAK-071 40 mg | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | 0.001870 L/h | Standard Deviation 0.0010016 |
| SRD: Cohort 6: TAK-071 80 mg | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | 0.001696 L/h | Standard Deviation 0.0015594 |
Secondary
Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants
Time frame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | Day -1 | 23.07 ng/mL | Standard Error 3.6855 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | Day 21 | 26.58 ng/mL | Standard Error 2.3659 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | Day -1 | 30.65 ng/mL | Standard Error 5.9433 |
| SRD: Cohort 1: TAK-071 1 mg | Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | Day 21 | 29.95 ng/mL | Standard Error 6.4071 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | Day -1 | 22.63 ng/mL | Standard Error 4.2697 |
| SRD: Cohort 2: TAK-071 3 mg | Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | Day 21 | 25.97 ng/mL | Standard Error 5.6163 |
Secondary
CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071
Time frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071 | 13.68 h*ng/mL | Standard Deviation 3.9324 |
Secondary
CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071
Time frame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071 | 360.9 h*ng/mL | Standard Deviation 73.78 |
Secondary
CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071
Time frame: Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071 | 0.008988 ng/mL | Standard Deviation 0.0051582 |
Secondary
CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071
Time frame: Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071 | 0.01144 ng/mL | Standard Deviation 0.0012682 |
Secondary
Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose and pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 1 | 0.1145 fraction of drug excreted | Standard Deviation 0.10375 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 28 | 0.4005 fraction of drug excreted | Standard Deviation 0.34935 |
| SRD: Cohort 1: TAK-071 1 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 1 | 0.2314 fraction of drug excreted | Standard Deviation 0.10539 |
| SRD: Cohort 1: TAK-071 1 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 28 | 0.3771 fraction of drug excreted | Standard Deviation 0.25202 |
| SRD: Cohort 2: TAK-071 3 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 1 | 0.2150 fraction of drug excreted | Standard Deviation 0.15468 |
| SRD: Cohort 2: TAK-071 3 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | Day 28 | 0.4321 fraction of drug excreted | Standard Deviation 0.41878 |
Secondary
Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants
Time frame: Pre-dose on Days 1 and 21 and at multiple time points (up to 24 hours) post-dose for Cohorts 7 and 8 and Pre-dose on Days 1 and 28 and multiple time points (up to 96 hours) post-dose for Cohort 9
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.05003 fraction of drug excreted | Standard Deviation 0.059956 |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 21 | 0.3022 fraction of drug excreted | Standard Deviation 0.14116 |
| SRD: Cohort 1: TAK-071 1 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.06636 fraction of drug excreted | Standard Deviation 0.038484 |
| SRD: Cohort 1: TAK-071 1 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 21 | 0.2659 fraction of drug excreted | Standard Deviation 0.16013 |
| SRD: Cohort 2: TAK-071 3 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 1 | 0.3286 fraction of drug excreted | Standard Deviation 0.12842 |
| SRD: Cohort 2: TAK-071 3 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | Day 28 | 0.7460 fraction of drug excreted | Standard Deviation 0.5268 |
Secondary
Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Measurable TAK-071 was not detected in urine for Cohort 1 (TAK-071 1 mg). Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.05771 fraction of drug excreted | Standard Deviation 0.052687 |
| SRD: Cohort 1: TAK-071 1 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.1813 fraction of drug excreted | Standard Deviation 0.069494 |
| SRD: Cohort 2: TAK-071 3 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.2877 fraction of drug excreted | Standard Deviation 0.11934 |
| SRD: Cohort 3: TAK-071 9 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.2140 fraction of drug excreted | Standard Deviation 0.13039 |
| SRD: Cohort 4: TAK-071 20 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.1131 fraction of drug excreted | Standard Deviation 0.056006 |
| SRD: Cohort 5: TAK-071 40 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.1377 fraction of drug excreted | Standard Deviation 0.081035 |
| SRD: Cohort 6: TAK-071 80 mg | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | 0.09408 fraction of drug excreted | Standard Deviation 0.068159 |
Secondary
Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071
Time frame: Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071 | 0.009098 Ratio | Standard Deviation 0.003453 |
Secondary
Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071
Time frame: Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose Cohort 9
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071 | 0.01140 Ratio | Standard Deviation 0.0014959 |
Secondary
Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071
A linear mixed effect model on the natural log-transformed parameters was performed with day as a fixed effect and participant as a random effect. Ratio is the exponentiated geometric mean value Day 21/Day -1 on the original scale.
Time frame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071 | 1.155 Ratio |
| SRD: Cohort 1: TAK-071 1 mg | Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071 | 1.055 Ratio |
| SRD: Cohort 2: TAK-071 3 mg | Ratio of Geometric Mean of AUC(0-24) for Donepezil After 21 Daily Doses of TAK-071 | 1.106 Ratio |
Secondary
Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071
A linear mixed effect model on the natural log-transformed parameters was performed with day as a fixed effect and participant as a random effect. Ratio is the exponentiated geometric mean value Day 21/Day -1 on the original scale.
Time frame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. Here, number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071 | 1.160 Ratio |
| SRD: Cohort 1: TAK-071 1 mg | Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071 | 0.969 Ratio |
| SRD: Cohort 2: TAK-071 3 mg | Ratio of Geometric Mean of Cmax for Donepezil After 21 Daily Doses of TAK-071 | 1.121 Ratio |
Secondary
Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect
Time frame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect | 48.804 hours |
| SRD: Cohort 1: TAK-071 1 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect | 50.590 hours |
| SRD: Cohort 2: TAK-071 3 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect | 49.796 hours |
Secondary
Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 50.894 hours |
| SRD: Cohort 1: TAK-071 1 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 35.567 hours |
| SRD: Cohort 2: TAK-071 3 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 54.998 hours |
| SRD: Cohort 3: TAK-071 9 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 57.504 hours |
| SRD: Cohort 4: TAK-071 20 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 53.219 hours |
| SRD: Cohort 5: TAK-071 40 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 55.246 hours |
| SRD: Cohort 6: TAK-071 80 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 51.933 hours |
| MRD: Placebo Cohorts 7-9 | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | 58.165 hours |
Secondary
Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil
Time frame: Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 42.923 hours |
| SRD: Cohort 1: TAK-071 1 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 33.505 hours |
| SRD: Cohort 2: TAK-071 3 mg | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | 50.077 hours |
Secondary
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants
Time frame: Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | Day -1 | 3.000 hours |
| SRD: Placebo Cohorts 1-6, 18 and 19 | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | Day 21 | 2.508 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | Day -1 | 3.000 hours |
| SRD: Cohort 1: TAK-071 1 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | Day 21 | 3.500 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | Day -1 | 3.008 hours |
| SRD: Cohort 2: TAK-071 3 mg | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | Day 21 | 2.500 hours |
Secondary
Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect
Time frame: Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | 44.43 L | Standard Deviation 7.1688 |
| SRD: Cohort 1: TAK-071 1 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | 46.74 L | Standard Deviation 7.3595 |
| SRD: Cohort 2: TAK-071 3 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | 43.82 L | Standard Deviation 6.3235 |
Secondary
Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 43.63 L | Standard Deviation 10.532 |
| SRD: Cohort 1: TAK-071 1 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 44.96 L | Standard Deviation 5.7176 |
| SRD: Cohort 2: TAK-071 3 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 48.10 L | Standard Deviation 9.0985 |
| SRD: Cohort 3: TAK-071 9 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 54.62 L | Standard Deviation 9.8917 |
| SRD: Cohort 4: TAK-071 20 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 321.0 L | Standard Deviation 656.95 |
| SRD: Cohort 5: TAK-071 40 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 59.54 L | Standard Deviation 11.499 |
| SRD: Cohort 6: TAK-071 80 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 70.25 L | Standard Deviation 9.1042 |
| MRD: Placebo Cohorts 7-9 | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | 84.47 L | Standard Deviation 16.851 |
Secondary
Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil
Time frame: Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose
Population: PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SRD: Placebo Cohorts 1-6, 18 and 19 | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | 59.03 L | Standard Deviation 5.5208 |
| SRD: Cohort 1: TAK-071 1 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | 62.40 L | Standard Deviation 17.164 |
| SRD: Cohort 2: TAK-071 3 mg | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071 + Donepezil | 63.52 L | Standard Deviation 11.895 |