Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Danavorexton
TAK-925 · 3 trials · 4 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.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3. |
| Danavorexton LD | EXPERIMENTAL | Danavorexton LD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3. |
| Danavorexton HD | EXPERIMENTAL | Danavorexton HD regimen, infusion, intravenously, administered overnight for approximately 10-hours on Days 1 to 2 in each Treatment Period 1, 2, or 3. |
| 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). |
| 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. |
| Name | Type | Description |
|---|---|---|
| Danavorexton | DRUG | Danavorexton intravenous infusion. |
| Placebo | DRUG | Placebo intravenous infusion. |
| TAK-925 | DRUG | TAK-925 IV infusion |
Inclusion Criteria: 1. Has OSA diagnosed according to the International Classification of Sleep Disorders-3 (ICSD-3) criteria and an AHI of 12-50 events/hour sleep (documented by an in-clinic PSG or at-home sleep test within the last 12 months). Participants who do not have PSG results from within ...
TAK-925 is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited. It is being studied in Phase 1 clinical trials for narcolepsy and for obstructive sleep apnea in patients who experience excessive daytime sleepiness despite adequate use of continuous positive airway pressure (CPAP).
TAK-925 is being evaluated to treat narcolepsy and obstructive sleep apnea in participants who have excessive daytime sleepiness despite adequate use of continuous positive airway pressure (CPAP). It is investigational and has not been approved for any indication. Clinical testing to date has been limited to Phase 1 studies.
TAK-925 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the Phase 1 clinical trials evaluating the compound in narcolepsy and in obstructive sleep apnea with excessive daytime sleepiness.
TAK-925 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency. The completed Phase 1 studies enrolled a total of 57 participants across narcolepsy and obstructive sleep apnea populations.
TAK-925 has been studied in two completed Phase 1 trials. NCT03748979 evaluated safety, tolerability, pharmacokinetics and pharmacodynamics in healthy volunteers and participants with narcolepsy in Japan. NCT04091425 studied TAK-925 in participants with obstructive sleep apnea experiencing excessive daytime sleepiness despite adequate CPAP use in the United States.
The TAK-925 Phase 1 trials were randomized, double-blind and placebo-controlled. NCT03748979 enrolled 57 participants, including healthy volunteers and people with narcolepsy, in Japan. NCT04091425 enrolled 25 participants with obstructive sleep apnea and excessive daytime sleepiness in the United States. Both studies are completed.