| Primary | Percentage of Participants Who Experience 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. An AE can therefore be any unfavourable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. | Safety set included all participants who were enrolled and received study drug. | Posted | | Number | | percentage of participants | | Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohorts Pooled Placebo | TAK-915 placebo-matching suspension, orally, once on Day 1. | | OG001 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG004 | MRD Cohorts Pooled Placebo | TAK-915 placebo-matching suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 placebo-matching suspension, orally, once on Days 8 to 14. | | OG005 | MRD Cohort 5: TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14. | | OG006 | MRD Cohort 6: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14. | | OG007 | MRD Cohort 7: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14. | | OG008 | DDI Cohort 8: Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Days 1 and 16 (within 15 minutes after last dose of TAK-915). | | OG009 | DDI Cohort 8: TAK-915 100 mg | TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16. | | OG010 | DDI Cohort 8: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915). | | OG011 | BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | | OG012 | BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | | OG013 | BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. | | OG014 | ESSD Cohort 12: TAK-915 50 mg | TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000
- OG00116.7
- OG00233.3
- OG003
|
|
| |
| Primary | Percentage of Participants With Markedly Abnormal Safety Laboratory Tests | The percentage of participants with any markedly abnormal standard safety laboratory values, including haematology, serum chemistries, or urinalysis, during the treatment period. | Safety set included all participants who were enrolled and received study drug. | Posted | | Number | | percentage of participants | | Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohorts Pooled Placebo | TAK-915 placebo-matching suspension, orally, once on Day 1. | | OG001 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. |
|
| Primary | Percentage of Participants With Markedly Abnormal Vital Sign Measurements | The percentage of participants who meet markedly abnormal criteria for vital signs after dosing, including oral body temperature (temp.), respiration rate, pulse rate (PR) Systolic blood pressure (SBP) and Diastolic blood pressure (DBP) for assessment in positions of supine or standing. Vital signs were considered abnormal if they were beyond the values defined in categories. | Safety set included all participants who were enrolled and received study drug. | Posted | | Number | | percentage of participants | | Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohorts Pooled Placebo | TAK-915 placebo-matching suspension, orally, once on Day 1. | | OG001 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 3: TAK-915 200 mg |
|
| Primary | Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters | The percentage of participants who meet markedly abnormal criteria for ECG parameters as specified by the protocol and statistical analysis plan during the treatment period. ECG parameters were considered abnormal if they were beyond the values defined in categories. | Safety set included all participants who were enrolled and received study drug. | Posted | | Number | | percentage of participants | | Day 1 up to follow-up (SRD Cohorts: up to Day 13, MRD Cohorts: up to Day 26, DDI Cohort: up to Day 28, BA/FE Cohorts: up to Day 13, ESSD Cohort: up to Day 28) | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohorts Pooled Placebo | TAK-915 placebo-matching suspension, orally, once on Day 1. | | OG001 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 3: TAK-915 200 mg | |
|
| Primary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Median | Full Range | hr | | SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | |
|
| Primary | Cmax: Maximum Observed Plasma Concentration for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng/mL | | SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | |
|
| Primary | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. |
|
| Primary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1, 8 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. |
|
| Primary | AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Day 1 pre-dose and at multiple time points (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | | OG004 | MRD Cohort 5: TAK-915 30 mg |
|
| Primary | Rac(AUC): Accumulation Ratios Between Day 14 AUC(0-24) and Day 1 AUC(0-24) for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | Ratio | | Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | MRD Cohort 5: TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14. | | OG001 | MRD Cohort 6: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14. | | OG002 | MRD Cohort 7: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14. |
| |
| Primary | Rac(Cmax): Accumulation Ratios Between Day 14 Cmax and Day 1 Cmax for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | Ratio | | Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | MRD Cohort 5: TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14. | | OG001 | MRD Cohort 6: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14. | | OG002 | MRD Cohort 7: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14. |
| |
| Primary | Time Dependency Assessment From AUC(0-24) After Last Dose for TAK-915 on Day 14 in MRD Cohorts Compared to AUC(0-inf) After a Single Dose on Day 1 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ratio | | Days 1 and 14 pre-dose and at multiple time points (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | MRD Cohort 5: TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14. | | OG001 | MRD Cohort 6: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14. | | OG002 | MRD Cohort 7: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14. |
| |
| Primary | Cmax: Maximum Observed Plasma Concentration for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng/mL | | Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | DDI Cohort 7: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915). |
| |
| Primary | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for Midazolam Alone (Day 1) and in the Presence of TAK-915 (Day 16) in DDI Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | DDI Cohort 7: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915). |
| |
| Primary | AUC(0-24) for Midazolam After Single Dose (Day 1)/AUC(0-24) for Midazolam After 7 Daily Doses of TAK-915 (Day 16) in DDI Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | Ratio | | Days 1 and 16 pre-dose and at multiple timepoints (up to 24 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | DDI Cohort 7: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915). |
| |
| Secondary | Terminal Elimination Half-life (t1/2) for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Median | Full Range | hr | | SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | | OG004 |
|
| Secondary | CL/F: Apparent Clearance for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. Number of participants analysed is the participants who were evaluable in each cohort. | Posted | | Mean | Standard Deviation | L/hr | | SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. |
|
| Secondary | Apparent Volume of Distribution (Vz/F) for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | L | | SRD and ESSD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | |
|
| Secondary | Total Amount of Drug Excreted in Urine (Ae) for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng | | SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | | OG004 |
|
| Secondary | Fraction of Drug Excreted in Urine (Fe) for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | fraction excreted | | SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | |
|
| Secondary | Renal Clearance (CLr) for TAK-915 | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | mL/hr | | SRD Cohorts: Day 1 pre-dose and at multiple timepoints (up to 96 hours) post dose; MRD cohorts: Days 1 and 14 pre-dose and at multiple timepoints (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | | OG004 |
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-915 on Day 1 in DDI Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng/mL | | Days 1 at multiple time points (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | DDI Cohort 7: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915). |
| |
| Secondary | AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Postdose for TAK-915 on Day 1 in DDI Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Days 1 at multiple time points (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | DDI Cohort 7: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915). |
| |
| Secondary | AUC(0-tau): Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau Over a Dosing Interval Where Tau is the Length of the Dosing Interval for TAK-915 in DDI Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Days 16 at multiple time points (up to 96 hours) post dose | | | | ID | Title | Description |
|---|
| OG000 | DDI Cohort 7: TAK-915 + Midazolam 2 mg | Midazolam 2 mg suspension, orally, once on Day 1, followed by TAK-915 100 mg, suspension, orally, once on Day 3, followed by a 7-day washout period, followed by TAK-915 100 mg, suspension, orally, once, daily on Days 10 to 16 and Midazolam 2 mg solution, orally, once, on Day 16 (within 15 minutes after last dose of TAK-915). |
| |
| Secondary | Ratio of TAK-915 Metabolite Cmax to TAK-915 Cmax in SRD and MRD Cohorts | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ratio | | Day 1 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | | OG004 | MRD Cohort 5: TAK-915 30 mg |
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| Secondary | Ratio of TAK-915 Metabolite AUC(0-inf) to TAK-915 AUC(0-inf) in SRD Cohorts | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ratio | | Day 1 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
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| OG000 | SRD Cohort 1 TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1. | | OG001 | SRD Cohort 2: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1. | | OG002 | SRD Cohort 3: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1. | | OG003 | SRD Cohort 4: TAK-915 200 mg | TAK-915 200 mg suspension, orally via syringe, once on Day 1. | | OG004 | ESSD Cohort 12: TAK-915 50 mg |
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| Secondary | Ratio of TAK-915 Metabolite Area Under the Plasma Concentration-Time Curve From Time 0 to Time Tau Over a Dosing Interval [AUC(0-tau)] Where Tau is the Length of the Dosing Interval to TAK-915 AUC(0-tau) in MRD Cohorts | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ratio | | Day 14 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
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| OG000 | MRD Cohort 5: TAK-915 30 mg | TAK-915 30 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 30 mg suspension, orally, once on Days 8 to 14. | | OG001 | MRD Cohort 6: TAK-915 100 mg | TAK-915 100 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 100 mg suspension, orally, once on Days 8 to 14. | | OG002 | MRD Cohort 7: TAK-915 200 mg | TAK-915 200 mg suspension, orally, once on Day 1, followed by a 7-day washout period, followed by TAK-915 200 mg suspension, orally, once on Days 8 to 14. |
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| Secondary | Cmax: Maximum Observed Plasma Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng/mL | | Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
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| OG000 | BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | | OG001 | BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | | OG002 | BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. |
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| Secondary | AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
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| OG000 | BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | | OG001 | BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | | OG002 | BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. |
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| Secondary | AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | ng*hr/mL | | Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
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| OG000 | BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | | OG001 | BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | | OG002 | BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. |
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| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Median | Full Range | hr | | Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
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| OG000 | BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | | OG001 | BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | | OG002 | BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. |
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| Secondary | Terminal Elimination Half-life (t1/2) for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Median | Full Range | hr | | Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
|---|
| OG000 | BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | | OG001 | BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | | OG002 | BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. |
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| Secondary | λz: Terminal Elimination Rate Constant for TAK-915 and TAK-915 Metabolite M-I in BA/FE Cohort | | Pharmacokinetic set included all participants who received study drug and have at least 1 measurable plasma concentration or amount of drug in the urine for either TAK-915 or its metabolite M-I or for midazolam or its metabolite 1-hydroxymidazolam. | Posted | | Mean | Standard Deviation | 1/hr | | Day 1 of Periods 1, 2 and 3 predose and at multiple time points (up to 96 hours) post-dose | | | | ID | Title | Description |
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| OG000 | BA/FE Cohort Regimen A | TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of ant period. | | OG001 | BA/FE Cohort Regimen B | TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of any Period. | | OG002 | BA/FE Cohort Regimen C | TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of any period. |
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