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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 small molecule being developed by Takeda Pharmaceutical Company Limited. It has been studied in Phase 1 clinical trials in healthy participants and healthy volunteers. These trials evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug. TAK-994 is not approved and remains in clinical development.
TAK-994 is being studied for use in healthy participants and healthy volunteers. The clinical trials have focused on evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics. One trial also examined its effects in an acute sleep phase delay paradigm in healthy male participants. The drug is investigational and not yet approved for any condition.
TAK-994 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has sponsored multiple Phase 1 clinical trials of TAK-994 in the United States. These trials have been completed and involved healthy participants and healthy volunteers.
TAK-994 is in Phase 1 clinical development. All completed trials for TAK-994 are Phase 1 studies. These trials have been completed, and the drug remains investigational. TAK-994 is not FDA approved and is still in the early stages of clinical testing.
TAK-994 has been studied in several completed Phase 1 trials, including NCT03933488, NCT04551079, NCT04745767, and NCT04833049. These trials enrolled healthy participants and healthy volunteers in the United States. They evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics, with one trial also examining an acute sleep phase delay paradigm.
TAK-994 is the drug name used in clinical trials. No alternative names for TAK-994 have been reported in the trial records. The drug is consistently referred to as TAK-994 across the completed Phase 1 studies.