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Also known as TAK-994 Oral Tablet
TAK-994 · 4 trials · 2 indications
MWT is a validated objective measure that evaluates a person's ability to remain awake under soporific conditions for a defined period of time. Tendency to fall asleep is measured via electroencephalography-derived sleep latency. Mean sleep latency: mean time to sleep onset, over 4 MWT sessions (at approximately 2, 4, 6, and 8 hours after initial dosing).
| Arm | Type | Description |
|---|---|---|
| TAK-994 Dose 1 + [14C]TAK-994 Dose 2 + [14C]TAK-994 Dose 3 | EXPERIMENTAL | TAK-994 Dose 1, tablet, orally, on Day 1, followed by \[14C\]TAK-994 Dose 2, infusion, intravenously, on Day 1 of Part A, followed by a washout period of at least 8 days, further followed by \[14C\]TAK-994 Dose 3, suspension, orally, on Day 1 of Part B. |
| Group 1: A1(T1), B(T2), C(T2 Fed) | EXPERIMENTAL | Participants will be randomly placed into 6 sequences within Group 1. All participants in Group 1 will receive TAK-994 as Treatment A1 (T1 Formulation) and Treatment B (T2 Formulation) under fasted conditions and Treatment C (T2 Formulation) under fed conditions at different times within three periods. |
| Group 2: A2(T1), D(T3), E(T3 Fed) | EXPERIMENTAL | Participants will be randomly placed into 6 sequences within Group 2. All participants in Group 2 will receive TAK-994 as Treatment A2 (T1 Formulation) and Treatment D (T3 Formulation) under fasted conditions and Treatment E (T3 Formulation) under fed conditions at different times within three periods. |
| Group 3: A3(T1), F(T4), G(T4 Fed), H(T5) | EXPERIMENTAL | Participants will be randomly placed into 6 sequences within Group 3. Participants in Group 3 will receive TAK-994 as Treatment A3 (T1 Formulation), Treatment F (T4 Formulation), and Treatment F (T5 Formulation) under fasted conditions and Treatment G (T4 Formulation) under fed conditions at different times within 4 periods. |
| TAK-994 Dose A+ Placebo + TAK-994 Dose B | EXPERIMENTAL | TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 Dose B tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period. |
| TAK-994 Dose B + TAK-994 Dose A + Placebo | EXPERIMENTAL | TAK-994 Dose B tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period. |
| Placebo + TAK-994 Dose B+ TAK-994 Dose A | EXPERIMENTAL | TAK-994 placebo-matching tablets, orally, on Days 1 and 2 of Treatment Period 1, followed by TAK-994 Dose B tablets orally, on Days 1 and 2 of Treatment Period 2, further followed by TAK-994 Dose A tablets, orally, on Days 1 and 2 of Treatment Period 3. A Washout Period of at least 7 days will be maintained between each treatment period. |
| TAK-994: Part A | EXPERIMENTAL | TAK-994 tablet or matching placebo, orally, once on Day 1 to healthy non-Japanese participants. Sentinel dosing will be done in the first 2 cohorts of Part A (Cohorts A1 and A2 \[fasted and fed dosing conditions\]). Dose escalation in Cohorts A2 to A6 will be based on emerging safety, tolerability, and PK (pharmacokinetic) data from previous cohorts. |
| TAK-994: Part B | EXPERIMENTAL | TAK-994 tablet or matching placebo, orally, once daily or twice daily from Day 1 to Day 14 to healthy non-Japanese participants. Dose escalation will be based on review of the emerging safety, PK, and PD (pharmacodynamic) data from Part A. Fixed-dose titration regimens may also be evaluated based on review of the emerging safety, PK, and tolerability data from previous cohorts. |
| TAK-994: Part C | EXPERIMENTAL | TAK-994 tablet or matching placebo, orally, once daily or twice daily from Day 1 to Day 7 to healthy non-Japanese participants. Dose will be determined based on previous multiple-rising dose (MRD) cohorts. |
| TAK-994: Part D | EXPERIMENTAL | TAK-994 tablet or matching placebo, orally, once daily or twice daily from Day 1 to Day 14 to healthy non-Japanese elderly participants. Dose will be determined based on previous MRD cohorts. Fixed-dose titration regimens may also be evaluated based on review of the emerging safety, PK, and tolerability data from previous cohorts. |
| TAK-994: Part E | EXPERIMENTAL | TAK-994 tablet or matching placebo, orally, once or twice on Day 1, followed by a washout period of 2 days and on Day 4 and continue to Day 17 to healthy Japanese participants. Dose will be determined based on previous MRD cohorts. Fixed-dose titration regimens may also be evaluated based on review of the emerging safety, PK, and tolerability data from previous cohorts. |
| Name | Type | Description |
|---|---|---|
| TAK-994 Oral Tablet | DRUG | TAK-994 tablet. |
| [14C]TAK-994 Intravenous Infusion | DRUG | \[14C\]TAK-994 intravenous infusion. |
| [14C]TAK-994 Oral Suspension | DRUG | \[14C\]TAK-994 oral suspension. |
| TAK-994 | DRUG | T2 formulation. |
| Placebo | DRUG | TAK-994 placebo-matching tablets. |
| TAK-994 Placebo | DRUG | TAK-994 placebo-matching tablets. |
Inclusion Criteria: 1. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than (\<) 32.0 kilogram per square meter (kg/m\^2) at the screening. 2. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardio...
TAK-994 is an investigational oral small molecule developed by Takeda Pharmaceutical Company Limited. It has been studied in Phase 1 clinical trials in healthy adult participants, including studies of its safety, tolerability, pharmacokinetics, and pharmacodynamics. All four of its recorded trials are completed, and no active trials are currently listed.
TAK-994 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored all four of the Phase 1 trials of TAK-994 conducted in the United States, which together enrolled approximately 200 healthy participants.
TAK-994 is in Phase 1 development. Four Phase 1 trials have been conducted, and all four are completed, with no active trials listed. The studies were randomized, double-blind, and controlled, and enrolled healthy adult volunteers rather than patients with a specific disease.
TAK-994 has been evaluated in four completed Phase 1 trials: NCT03933488, which enrolled 121 healthy participants; NCT04745767, which compared different forms of TAK-994 in 54 healthy adults; NCT04551079, which studied oral TAK-994 in an acute sleep phase delay paradigm in 19 healthy male participants; and NCT04833049, an absorption, metabolism, and excretion study in 6 healthy male adults.
Yes, TAK-994 Oral Tablet is another name for TAK-994. Both names refer to the same investigational small molecule developed by Takeda Pharmaceutical Company Limited, and searches using either name point to the same Phase 1 development program.
Across its four completed Phase 1 trials, TAK-994 enrolled approximately 200 participants in total. Enrollment ranged from 6 participants in the absorption, metabolism, and excretion study to 121 participants in the largest safety, tolerability, pharmacokinetics, and pharmacodynamics study. All trials were conducted in the United States.