Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-438 OD · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Study 1, TAK-438 OD + TAK-438 | EXPERIMENTAL | One TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9). |
| Study 1, TAK-438 + TAK-438 OD | EXPERIMENTAL | One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 1 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally without water under fasted condition, on Period 2 Day 1 in Study 1 (Day 9). |
| Study 2, TAK-438 OD + TAK-438 | EXPERIMENTAL | One TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9). |
| Study 2, TAK-438 + TAK-438 OD | EXPERIMENTAL | One TAK-438 20 mg tablet, orally with water under fasted condition, on Period 1 Day 1 in Study 2 (Day 1), followed by a wash-out period (Days 2 to 8), followed by one TAK-438 OD 20 mg tablet, orally with water under fasted condition, on Period 2 Day 1 in Study 2 (Day 9). |
| Name | Type | Description |
|---|---|---|
| TAK-438 OD | DRUG | TAK-438 OD tablet |
| TAK-438 | DRUG | TAK-438 tablet |
Inclusion Criteria: 1. In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant signs and dates a written, informed consent form prior to the initiation of any study procedures. 3. The participan...
TAK-438 OD is an orally disintegrating tablet formulation developed by Takeda Pharmaceutical Company Limited. It is a small molecule drug candidate that has been studied in a Phase 1 bioequivalence trial in Japanese healthy adult male volunteers. The specific therapeutic indication for this formulation has not been disclosed.
TAK-438 OD is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program for this orally disintegrating tablet formulation.
TAK-438 OD is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.
TAK-438 OD has been evaluated in one completed Phase 1 trial, NCT03808493, titled "A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet." The trial enrolled 48 Japanese healthy adult male participants in Japan and used a randomized, controlled design.
TAK-438 OD refers specifically to the orally disintegrating tablet formulation of TAK-438. The "OD" designation distinguishes this formulation from other dosage forms of the same compound.