Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-925 · 4 trials · 5 indications
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 unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Clinical laboratory evaluations include hematology, blood chemistry, and urinalysis.
Vital signs include heart rate, respiratory rate, systolic blood pressure (SBP) and diastolic blood pressure (DBP).
A standard 12-lead ECG will be performed.
An Adverse Event (AE) was 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 unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
The MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. This tendency to fall asleep is measured via electroencephalography-derived sleep latency. Sleep onset is defined as the first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials were ended after 40 minutes if no sleep occurs, or after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep, or 1 epoch of any other stage of sleep. If no sleep has been observed according to these rules, then the latency is defined as 40 minutes. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake.
Urine assessments were done only in Part 1, as planned.
Urine assessments were done only in Part 1, as planned.
Urine assessments were done only in Part 1, as planned.
| Arm | Type | Description |
|---|---|---|
| TAK-925 Dose A | EXPERIMENTAL | TAK-925 dose A intravenous (IV) infusion in each treatment sequence (crossover design). |
| TAK-925 Dose B | EXPERIMENTAL | TAK-925 dose B IV infusion in each treatment sequence (cross over design). |
| Placebo | PLACEBO_COMPARATOR | TAK-925 placebo-matching IV infusion in each treatment sequence (crossover design). |
| Cohort A1; TAK-925 (Dose Level A1) | EXPERIMENTAL | TAK-925, Dose Level A, once daily for up to 7 days in healthy participants. |
| Cohort A2; TAK-925 (Dose Level A2) | EXPERIMENTAL | TAK-925, Dose Level A2, once daily for up to 7 days in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A3; TAK-925 (Dose Level A3) | EXPERIMENTAL | TAK-925, Dose Level A3, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A4; TAK-925 (Dose Level A4) | EXPERIMENTAL | TAK-925, Dose Level A4, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A5; TAK-925 (Dose Level A5) | EXPERIMENTAL | TAK-925, Dose Level A5, once daily for up to 7 days in healthy participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort A6; TAK-925 (Dose Level A6) | EXPERIMENTAL | TAK-925, Dose Level A6, once daily for up to 7 days in healthy elderly participants. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part A (Cohorts A1-A6); TAK-925 Placebo | PLACEBO_COMPARATOR | TAK-925 Placebo, once daily for up to 7 days in healthy participants. |
| Cohort B1; TAK-925 (Dose Level B1) | EXPERIMENTAL | TAK-925, Dose Level B1, once daily for up to 7 days in participants with narcolepsy. |
| Cohort B2; TAK-925 (Dose Level B2) | EXPERIMENTAL | TAK-925, Dose Level B2, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort B3; TAK-925 (Dose Level B3) | EXPERIMENTAL | TAK-925, Dose Level B3, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort B4; TAK-925 (Dose Level B4) | EXPERIMENTAL | TAK-925, Dose Level B4, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part B (Cohorts B1-B4); TAK-925 Placebo | PLACEBO_COMPARATOR | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
| Cohort C1; TAK-925 (Dose Level C1) | EXPERIMENTAL | TAK-925, Dose Level C1, once daily for up to 7 days in participants with narcolepsy. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Cohort C2; TAK-925 (Dose Level C2) | EXPERIMENTAL | TAK-925, Dose Level C2, once daily for up to 7 days in participants with narcolepsy. This group is an additional optional cohort and dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| Part C (Cohorts C1-C2); TAK-925 Placebo | PLACEBO_COMPARATOR | TAK-925 Placebo, once daily for up to 7 days in participants with narcolepsy. |
| Cohort A'1; TAK-925 (Dose Level A'1) | EXPERIMENTAL | TAK-925, Dose Level A'1, single dose in healthy participants. |
| Cohort A'2; TAK-925 (Dose Level A'2) | EXPERIMENTAL | TAK-925, Dose Level A'2, single dose in healthy participants. Dose level will be determined based on the data of safety, tolerability and PK data from previous cohorts. |
| TAK-925 Low Dose + Placebo + TAK-925 High Dose + Modafinil | EXPERIMENTAL | TAK-925 low dose milligram (mg), intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001. |
| TAK-925 High Dose + TAK-925 Low Dose + Modafinil + Placebo | EXPERIMENTAL | TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001. |
| Modafinil + TAK-925 High Dose + Placebo + TAK-925 Low Dose | EXPERIMENTAL | Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by placebo once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001. |
| Placebo + Modafinil + TAK-925 Low Dose + TAK-925 High Dose | EXPERIMENTAL | Placebo, once on Day 1 of Intervention Period 1, followed by a minimum of 7-days washout period, further followed by Modafinil 300 mg, tablet, orally, once on Day 1 of Intervention Period 2, followed by a minimum of 7-days washout period, further followed by TAK-925 low dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 3, followed by a minimum of 7-days washout period, further followed by TAK-925 high dose mg, intravenously, administered as 9-hour infusion, once on Day 1 of Intervention Period 4. TAK-925 dose will be decided based on the availability of safety, tolerability and PK data from ongoing study TAK-925-1001. |
| Part 1: TAK-925 (Cohort 1; Dose Level 1) | EXPERIMENTAL | TAK-925, Intravenous single administration. Healthy adults will be enrolled in double blind manner. |
| Part 1: TAK-925 (Cohort 2; Dose Level 2) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 2). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner. |
| Part 1: TAK-925 (Cohort 1; Dose Level 3) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 3). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner. |
| Part 1: TAK-925 (Cohort 2; Dose Level 4) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 4). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner. |
| Part 1: TAK-925 (Cohort 1; Dose Level 5) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 5). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner. |
| Part 1: TAK-925 (Cohort 2; Dose Level 6) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 6). Dose selected based on safety, tolerability and PK data from previous Cohorts. Healthy adults will be enrolled in double blind manner. |
| Part 1: Placebo (Cohort 1-2) | PLACEBO_COMPARATOR | TAK-925 Placebo, Intravenous single administration. Healthy adults will be enrolled in double blind manner. |
| Part 1: TAK-925 (Cohort 3; Dose Level 5) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 5). Healthy elderly participants will be enrolled in double blind manner. |
| Part 1: Placebo (Cohort 3) | PLACEBO_COMPARATOR | TAK-925 Placebo, Intravenous single administration. Healthy elderly participants will be enrolled in double blind manner. |
| Part 1: TAK-925 (Cohort 4; Dose Level 5) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose level will be determined by targeted plasma level of TAK-925 (Dose level 5). Healthy adults will be enrolled in non-blinded manner. |
| Part 2: TAK-925 TBD (Cohort 5) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose in Cohort 5 will be based on safety and tolerability in the Part 1. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open). |
| Part 2: TAK-925 TBD (Cohort 6) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose in Cohort 6 TBD based on safety, tolerability, PK data, and results of the Maintenance Wakefulness Test (MWT) from previous Cohorts. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open). |
| Part 2: TAK-925 TBD (Cohort 7) | EXPERIMENTAL | TAK-925, Intravenous single administration. Dose in Cohort 7 TBD based on safety, tolerability, PK data, and results of the Maintenance of Wakefulness Test (MWT) from previous Cohorts. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open). |
| Part 2: Placebo (Cohort 5-7) | PLACEBO_COMPARATOR | TAK-925 Placebo, Intravenous single administration. Patients with Narcolepsy will be enrolled in double blind manner (sponsor open). |
| Name | Type | Description |
|---|---|---|
| TAK-925 | DRUG | TAK-925 IV infusion |
| Placebo | DRUG | TAK-925 placebo-matching IV infusion |
| TAK-925 Placebo | DRUG | TAK-925 placebo-matching given as saline intravenous infusion. |
| Modafinil | DRUG | Modafinil tablets. |
| Modafinil Placebo | DRUG | Modafinil placebo-matching tablet. |
Inclusion Criteria: * Has OSA diagnosed according to the international classification of sleep disorders-3 (ICSD-3) criteria and with current use of CPAP. * Has a complaint of EDS despite "consistent use" of CPAP as defined by machine tracking time as having at least 4 hours of CPAP use/night on at...
TAK-925 is an investigational small molecule being studied in neurology for conditions including obstructive sleep apnea with excessive daytime sleepiness, narcolepsy, and healthy volunteer studies. It is in Phase 1 clinical development and is not approved for any use.
TAK-925 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting Phase 1 clinical trials of the drug in Japan and the United States.
TAK-925 is in Phase 1 clinical development. Multiple Phase 1 trials have been completed, including studies in healthy volunteers, participants with narcolepsy, and participants with obstructive sleep apnea. The drug remains investigational.
TAK-925 has completed several Phase 1 trials, including NCT03332784 in healthy participants and patients with narcolepsy in Japan, NCT03522506 in sleep-deprived healthy adults in the United States, NCT03748979 in healthy participants and narcolepsy patients in Japan, and NCT04091425 in obstructive sleep apnea patients with excessive daytime sleepiness.
No, TAK-925 is a distinct investigational drug from TAK-994. TAK-925 is being studied for narcolepsy and obstructive sleep apnea, while TAK-994 is a separate compound. Each has its own clinical development program.