Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-418 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1: TAK-418 5 mg | EXPERIMENTAL | TAK-418 5 milligram (mg), capsule, orally, once on Day 1. |
| Cohort 2: TAK-418 15 mg | EXPERIMENTAL | TAK-418 15 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohort 3: TAK-418 30 mg Fasted + TAK-418 30 mg Fed | EXPERIMENTAL | TAK-418 30 mg, capsule, in fasted state, orally, once on Day 1, followed by a 28-day washout period, further followed by TAK-418 30 mg, capsule, in fed state, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohort 4: TAK-418 40 mg | EXPERIMENTAL | TAK-418 40 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohort 5: TAK-418 60 mg | EXPERIMENTAL | TAK-418 60 mg, capsule, orally, once on Day 1. Actual dose of TAK-418 may vary based on safety, tolerability and PK data from previous Cohorts. |
| Cohorts 1-5: Placebo | PLACEBO_COMPARATOR | TAK-418 placebo-matching, capsule, orally, once on Day 1. |
| Name | Type | Description |
|---|---|---|
| TAK-418 | DRUG | TAK-418 Capsule. |
| TAK-418 Placebo | DRUG | TAK-418 placebo-matching capsules. |
Inclusion Criteria: 1. Is a male or female participants with a body mass index (BMI) within the range of 18.5 -30.0 kilogram per square meter (kg/m\^2) at the Screening Visit. 2. Is a nonsmoker who has not used tobacco or nicotine-containing products (example, nicotine patch) for at least 6 months ...
TAK-418 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed, so its therapeutic use is not publicly defined.
TAK-418 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 1 study of the compound conducted in the United States. No partner or collaborator on the program has been disclosed.
TAK-418 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA for any indication.
TAK-418 has been evaluated in one completed Phase 1 trial, NCT03228433, titled a study to evaluate safety, tolerability and pharmacokinetics of ascending oral single dose of TAK-418 in healthy participants. The trial enrolled 40 healthy adults in the United States and was randomized, double blind, and placebo controlled.
The Phase 1 trial NCT03228433 was a randomized, double blind, placebo controlled study of ascending oral single doses of TAK-418. It enrolled 40 healthy participants aged 18 years and older in the United States and assessed safety, tolerability, and pharmacokinetics. The study has been completed.