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 of TAK-438, a small molecule being developed by Takeda Pharmaceutical Company Limited. It is intended for use in Japanese healthy adult males, as studied in a Phase 1 clinical trial. The drug is currently in early clinical development.
TAK-438 OD is developed by Takeda Pharmaceutical Company Limited, a biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. The drug is a small molecule formulation currently in Phase 1 clinical development.
TAK-438 OD is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial involving Japanese healthy adult male participants.
TAK-438 OD has one completed clinical trial, identified as NCT03808493. This Phase 1 study was a bioequivalence study of the TAK-438 orally disintegrating tablet. The trial enrolled 48 Japanese healthy adult male participants and was conducted in Japan.
TAK-438 OD is an orally disintegrating tablet formulation of the drug TAK-438. The OD designation refers to the orally disintegrating dosage form, which is designed to dissolve quickly in the mouth. The active ingredient is the same as in other TAK-438 formulations.