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 developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical trial in healthy adult male volunteers in Japan. The specific therapeutic indication for TAK-438ASA has not been publicly disclosed.
TAK-438ASA is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating this small molecule candidate.
TAK-438ASA is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory authority. The Phase 1 program consists of one completed trial with 276 participants.
TAK-438ASA has been evaluated in one completed Phase 1 trial, NCT03456960, titled A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet. The trial enrolled 276 healthy male volunteers in Japan and was randomized and controlled.
The therapeutic use of TAK-438ASA has not been publicly disclosed. The only completed clinical trial of TAK-438ASA was conducted in healthy volunteers to assess bioequivalence and food effect, not in patients with a specific disease.