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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04745767 | A Study of Different Forms of TAK-994 in Healthy Adults | PHASE1 | COMPLETED | 54 | — | — | Feb 16, 2021 | Apr 5, 2021 | Apr 22, 2021 | 2 | United States |
| NCT03933488 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Participants | PHASE1 | COMPLETED | 121 | — | — | May 1, 2019 | Mar 29, 2020 | Jun 24, 2020 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| 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: 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 | DRUG | T2 formulation. |
| 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 or equal to (\<=) 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 ...