Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02584569 | Phase 1 TAK-915 Single-Dose Positron Emission Tomography (PET) Occupancy Study | PHASE1 | COMPLETED | 12 | — | — | Nov 1, 2015 | Apr 1, 2016 | Jul 21, 2016 | 1 | United States |
| NCT02461160 | Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study | PHASE1 | COMPLETED | 88 | — | — | May 12, 2015 | Aug 1, 2016 | Feb 15, 2019 | 1 | United States |
Assessed for each subject using the PET ligand \[18F\]MNI-794 after single dosing of TAK-915, obtained from non-displaceable binding potential (BPnd).
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.
The percentage of participants with any markedly abnormal standard safety laboratory values, including haematology, serum chemistries, or urinalysis, during the treatment period.
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.
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.
| Arm | Type | Description |
|---|---|---|
| TAK-915 | EXPERIMENTAL | TAK-915 100 mg suspension, orally, once on Day 1. Additional TAK-915 dose levels may be incorporated based on dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data. |
| SRD Cohorts 1-3: Placebo | PLACEBO_COMPARATOR | TAK-915 placebo-matching suspension, orally, once on Day 1. |
| SRD Cohort 1 TAK-915 30 mg | EXPERIMENTAL | TAK-915 30 mg suspension, orally, once on Day 1. |
| SRD Cohort 2: TAK-915 100 mg | EXPERIMENTAL | TAK-915 100 mg suspension, orally, once on Day 1. |
| SRD Cohort 3: TAK-915 200 mg | EXPERIMENTAL | TAK-915 200 mg suspension, orally, once on Day 1. |
| MRD Cohorts 4-6 | PLACEBO_COMPARATOR | 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. |
| MRD Cohort 4: TAK-915 30 mg | EXPERIMENTAL | 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. |
| MRD Cohort 5: TAK-915 100 mg | EXPERIMENTAL | 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. |
| MRD Cohort 6: TAK-915 200 mg | EXPERIMENTAL | 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. |
| DDI Cohort 7: TAK-915 + Midazolam 2 mg | EXPERIMENTAL | 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). |
| BA/FE Cohort 8 Group 1: A,B,C | EXPERIMENTAL | Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1, followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3. Each period was separated out by a 6 to 14-day washout period. |
| BA/FE Cohort 9 Group 1: B,C,A | EXPERIMENTAL | Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2, followed by Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1. Each period was separated out by a 6 to 14-day washout period. |
| BA/FE Cohort 10 Group 1: C,A,B | EXPERIMENTAL | Regimen C: TAK-915 50 mg, tablet, orally under fed conditions once on Day 1 of Period 3 followed by Regimen A: TAK-915 50 mg, suspension, orally, under fasted conditions once on Day 1 of Period 1 followed by Regimen B: TAK-915 50 mg, tablet, orally, under fasted conditions once on Day 1 of Period 2. Each period was separated out by a 6 to 14-day washout period. |
| ESSD Cohort 11: TAK-915 50 mg | EXPERIMENTAL | TAK-915 50 mg, suspension, orally, under fasted conditions, once on Day 1 in participants aged 65 to 75 years. |
| Name | Type | Description |
|---|---|---|
| TAK-915 | DRUG | TAK-915 oral suspension |
| TAK-915 suspension | DRUG | TAK-915 oral suspension |
| Midazolam | DRUG | Midazolam oral solution |
| Placebo | DRUG | Placebo-matching TAK-915 suspension |
| TAK-915 tablet | DRUG | TAK-915 tablet |
Inclusion Criteria: 1. Is a healthy male, or female of non-childbearing potential, aged between 18 and 55 years, inclusive. 2. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2. Exclusion Criteria: 1. Has a known history or evidence of a clinically significant di...