| 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. | Safety Analysis Set (SAS) included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Day 1 up to Day 41 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG002 | 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. | | OG003 | 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. | | OG004 | 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. | | OG005 | 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. | | OG006 | 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 | | OG007 | 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. | | OG008 | 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. | | OG009 | 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. | | OG010 | 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. | | OG011 | 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. | | OG012 | 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. | | OG013 | 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. | | OG014 | 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. | | OG015 | MRD: Placebo Cohorts 13-15 | TAK-071 placebo-matching capsule, orally, once on Day 1 to Japanese healthy participants. | | OG016 | 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. | | OG017 | 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. | | OG018 | 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. | | OG019 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG020 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG021 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 | | OG022 | 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. | | OG023 | 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. | | OG024 | 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. | | OG025 | 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. | | OG026 | 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. | | OG027 | 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. | | OG028 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00025.0
- OG00133.3
- OG0020
- OG003
|
|
| |
| 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. | SAS included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Day 1 up to Day 41 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG002 | 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. | | OG003 | SRD: Cohort 3: TAK-071 9 mg | |
|
| 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. | SAS included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Day 1 up to Day 41 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG002 | 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. | | OG003 | SRD: Cohort 3: TAK-071 9 mg |
|
| 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. | SAS included all randomized participants who received at least 1 dose of study drug. | Posted | | Number | | percentage of participants | | Day 1 up to Day 41 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG002 | 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. | | OG003 | SRD: Cohort 3: TAK-071 9 mg |
|
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | | 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. | Posted | | Median | Full Range | hours | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | SRD: Cohort 4: TAK-071 20 mg | |
|
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Full Range | hours | | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 8] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 28] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Full Range | hours | | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 8] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Japanese Participants [Day 28] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 MRD Non-Japanese Participants [Day 21] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 Relative Bioavailability and Food Effect | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG001 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG002 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 |
| |
| Primary | Tmax: Time of First Occurrence of Cmax for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 Single-Rising Dose (SRD) Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | SRD: Cohort 4: TAK-071 20 mg | |
|
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 Multiple-Rising Dose (MRD) Non-Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 8] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 28] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 8] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Japanese Participants [Day 28] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 1] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 MRD Non-Japanese Participants [Day 21] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 Relative Bioavailability and Food Effect | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG001 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG002 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | SRD: Cohort 4: TAK-071 20 mg | |
|
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 8 and multiple time points (up to 24 hour) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 8 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 28 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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] | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Relative Bioavailability and Food Effect | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG001 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG002 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 |
| |
| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | SRD: Cohort 4: TAK-071 20 mg |
|
| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | SRD: Cohort 4: TAK-071 20 mg | |
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| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | AUClast: Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-071 MRD Non-Japanese | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG001 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG002 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 |
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| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. |
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| Secondary | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 Relative Bioavailability and Food Effect | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG001 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG002 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 |
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| Secondary | Terminal Disposition Phase Half-life (t1/2z) for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Day 1 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | L/h | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | SRD: Cohort 4: TAK-071 20 mg | |
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| Secondary | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | L/h | | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG001 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG002 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 |
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| Secondary | CL/F: Apparent Clearance After Extravascular Administration for TAK-071 SRD Non-Japanese Participants TAK-071+Donepezil | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | L/h | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 SRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | L | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD: Cohort 1: TAK-071 1 mg | TAK-071 1 mg, capsule, orally, once on Day 1 to non-Japanese healthy participants. | | OG001 | 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. | | OG002 | 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. | | OG003 | SRD: Cohort 4: TAK-071 20 mg | |
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| Secondary | Vz/F: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration for TAK-071 Relative Bioavailability and Food Effect | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | L | | Pre-dose on Day 21 and multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | Bioavailability (BA)/Food Effect: Cohort 17 Regimen A | TAK-071 10 mg capsule, orally once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG001 | BA/Food Effect: Cohort 17 Regimen B | TAK-071 10 mg tablet, orally, once on Day 1 in the fasted state in Period 1 or Period 2 or Period 3 | | OG002 | BA/Food Effect: Cohort 17 Regimen C | TAK-071 10 mg tablet, orally, once on Day 1 in the fed state in Period 1 or Period 2 or Period 3 |
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| 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 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | L | | Pre-dose on Day 1 and at multiple time points (up to 168 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | Ratio | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Accumulation Ratio Based on AUCτ (Rac[AUC]) for TAK-071 MRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | Ratio | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose on Day 28 and at multiple time points [up to 24 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | Accumulation Ratio Based on Plasma Cmax (Rac[Cmax]) for TAK-071 MRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose on Day 21 and at multiple time points [up to 24 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | | 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. | Posted | | Mean | Standard Deviation | mg | | Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | | 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. | Posted | | Mean | Standard Deviation | mg | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | AEt: Amount of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | mg | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 SRD Non-Japanese Participants | | 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. | Posted | | Mean | Standard Deviation | fraction of drug excreted | | Pre-dose on Day 1 and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Non-Japanese Participants | | 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. | Posted | | Mean | Standard Deviation | fraction of drug excreted | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Fet: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to Time t for TAK-071 MRD Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | fraction of drug excreted | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | CLR: Renal Clearance for TAK-071 SRD Non-Japanese Participants | | 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. | Posted | | Mean | Standard Deviation | L/h | | Pre-dose on Day 1 and at multiple time points [up to 96 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | CLR: Renal Clearance for TAK-071 MRD Non-Japanese Participants | | 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. | Posted | | Mean | Standard Deviation | L/h | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | CLR: Renal Clearance for TAK-071 MRD Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | L/h | | 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 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Secondary | CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071 | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | CSF Cmax: Maximum Observed Concentration in Cerebrospinal Fluid (CSF) for TAK-071 | | 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. | Posted | | Mean | Standard Deviation | ng/mL | | Pre-dose on Day 28 and at multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | CSF AUC(0-12): Area Under the CSF Concentration-time Curve From Time 0 to 12 Hours for TAK-071 | | 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. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 1 and at multiple time points (up to 12 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | CSF AUC(0-36): Area Under the CSF Concentration-time Curve From Time 0 to 36 Hours for TAK-071 | | 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. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Ratio of CSF AUC(0-12) to the Plasma AUC(0-12) for TAK-071 | | 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. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose on Day 1 and at multiple time points [up to 168 hours] post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Ratio of CSF AUC(0-36) to the Plasma AUC(0-36) for TAK-071 | | 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. | Posted | | Mean | Standard Deviation | Ratio | | Pre-dose on Day 28 and multiple time points (up to 36 hours) post-dose Cohort 9 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Donepezil MRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Median | Full Range | hours | | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Cmax: Maximum Observed Plasma Concentration for Donepezil MRD Non-Japanese Participants | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Error | ng/mL | | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Donepezil | | PK set included all participants who received study drug and had at least 1 measurable plasma concentration or amount of drug in the urine. | Posted | | Mean | Standard Deviation | h*ng/mL | | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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. | Posted | | Number | 90% Confidence Interval | Ratio | | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Number | 90% Confidence Interval | Ratio | | Pre-dose on Days -1 and 21 and multiple time points (up to 24 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|