Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-114 · 1 trial · 1 indication
Number of participants who had ECG shifts from "within normal limit" at baseline to "abnormal, clinically significant" after study drug administration were reported.
| Arm | Type | Description |
|---|---|---|
| Cohort 1A: TAK-114 10 mg | EXPERIMENTAL | Orally, once only. |
| Cohort 1B: TAK-114 10 mg | EXPERIMENTAL | Orally, once |
| Cohort 2A: TAK-114 20 mg | EXPERIMENTAL | Orally, once |
| Cohort 2B: TAK-114 20 mg | EXPERIMENTAL | Orally, once |
| Cohort 3A: TAK-114 50 mg | EXPERIMENTAL | Orally, once |
| Cohort 3B: TAK-114 50 mg | EXPERIMENTAL | Orally, once |
| Cohort 4a: TAK-114 20 mg | EXPERIMENTAL | Period 1: Single-dose administration in a fasting state Period 2: Single-dose administration 30 minutes after breakfast |
| Cohort 4b: TAK-114 20 mg | EXPERIMENTAL | Period 1: Single-dose administration 30 minutes after breakfast Period 2: Single-dose administration in a fasting state |
| Cohort 5A: TAK-114 20 mg | EXPERIMENTAL | Orally, Twice daily, 10 days |
| Cohort 5B: TAK-114 20 mg | EXPERIMENTAL | Orally, Twice daily, 10 days |
| Cohort 6A: TAK-114 50 mg | EXPERIMENTAL | Orally, Twice daily, 10 days |
| Cohort 6B: TAK-114 50 mg | EXPERIMENTAL | Orally, Twice daily, 10 days |
| Cohort 1A, 2A, 3A: TAK-114 placebo | PLACEBO_COMPARATOR | Cohort 1A, 2A, 3A: Orally, once |
| Cohort 5A: TAK-114 placebo | PLACEBO_COMPARATOR | Cohort 5A: Orally, Twice daily, 10 days |
| Cohort 6A: TAK-114 placebo | PLACEBO_COMPARATOR | Cohort 6A: Orally, Twice daily, 10 days |
| Name | Type | Description |
|---|---|---|
| TAK-114 10 mg capsule | DRUG | - |
| TAK-114 matched placebo | DRUG | - |
Inclusion Criteria: Healthy Japanese participants: * Must be willing to provide written informed consent and in the investigator's opinion able to comply with the study protocol. * Is aged 20 to 45 years, inclusive. * Weighs at least 50 kilogram (kg) and have a body mass index (BMI) between 18.5 a...
TAK-114 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical pharmacology trial in Japan. The compound is also referred to as the TAK-114 10 mg capsule. It is not an approved medicine and remains in clinical development.
TAK-114 is made and developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 1 clinical pharmacology study of the compound conducted in Japan.
TAK-114 is in Phase 1 clinical development. Its only recorded trial, NCT02286518, was a Phase 1 single- and multiple-dose study that has been completed. TAK-114 is investigational and has not been approved for any indication.
TAK-114 has been evaluated in one clinical trial, NCT02286518, titled the TAK-114 Single- and Multiple-Dose Phase 1 Study. The trial was completed, enrolled 82 participants, and was conducted in Japan in healthy male volunteers aged 20 years and older.
The TAK-114 Phase 1 study NCT02286518 was a randomized, double-blind, placebo-controlled trial. It enrolled 82 healthy male volunteers aged 20 years and older in Japan and evaluated single and multiple doses of TAK-114 in a clinical pharmacology setting. The study has been completed.