Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-438ASA · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Pilot phase of Study 1,TAK-438ASA + TAK-438 and Aspirin | EXPERIMENTAL | One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16). |
| Pilot phase of Study 1,TAK-438 and Aspirin + TAK-438ASA | EXPERIMENTAL | One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pilot phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by, one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pilot phase of Study 1 (Day 16). |
| Pivotal phase of Study 1, TAK-438ASA + TAK-438 and Aspirin | EXPERIMENTAL | One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16). |
| Pivotal phase of Study 1, TAK-438 and Aspirin + TAK-438ASA | EXPERIMENTAL | One TAK-438 10 mg tablet and one aspirin 100 mg tablet, orally without breakfast, on Day 1 of Period 1 in the Pivotal phase of Study 1 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in the Pivotal phase of Study 1 (Day 16). |
| Study 2,TAK-438ASA (Fasted + Fed condition) | EXPERIMENTAL | One TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 2 in Study 2 (Day 16). |
| Study 2,TAK-438ASA (Fed + Fasted condition) | EXPERIMENTAL | One TAK-438ASA tablet, orally 30 minutes after breakfast, on Day 1 of Period 1 in Study 2 (Day 1), followed by a washout period (Days 2 to 15), followed by one TAK-438ASA tablet, orally without breakfast, on Day 1 of Period 2 in Study 2 (Day 16). |
| Name | Type | Description |
|---|---|---|
| TAK-438ASA | DRUG | TAK-438ASA tablet. |
| TAK-438 | DRUG | TAK-438 tablet. |
| Aspirin | DRUG | Aspirin enteric-coated tablet. |
Inclusion Criteria: 1. In the opinion of the investigator or sub-investigator, participants are capable of understanding the procedures required for the study and complying with its requirements. 2. Participants sign and date an informed consent form by themselves prior to the initiation of any stu...
TAK-438ASA is an investigational small molecule being developed by Takeda Pharmaceutical Company Limited (TAK). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed clinical trial evaluating its bioequivalence and food effect.
TAK-438ASA is being studied for use in healthy volunteers. The completed Phase 1 trial, NCT03456960, evaluated the bioequivalence and food effect of TAK-438ASA tablet. The study enrolled 276 healthy male participants in Japan, aged 20 years and older.
TAK-438ASA is developed by Takeda Pharmaceutical Company Limited, a biopharmaceutical company listed on the stock exchange under the ticker TAK. The company is conducting clinical research on this investigational small molecule drug.
TAK-438ASA is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and there are no active trials currently ongoing for this drug.
TAK-438ASA has one completed clinical trial, NCT03456960, titled 'A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet'. This Phase 1 study was conducted in Japan with 276 healthy male volunteers, and it was a controlled, randomized trial.
TAK-438ASA is a distinct drug candidate from TAK-438, as indicated by its unique name. The drug is being developed by Takeda Pharmaceutical Company Limited. The clinical trial NCT03456960 specifically evaluates TAK-438ASA tablet, not TAK-438.