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Adjusted LOA
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TAK-123 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TAK-123 | EXPERIMENTAL | TAK-123 as 3.75 gram per square meter (g/m\^2) of sodium phenylacetate and 3.75 g/m\^2 of sodium benzoate, intravenous administration over 90 minutes, followed by TAK-123 as 3.75 g/m\^2 of sodium phenylacetate and 3.75 g/m\^2 of sodium benzoate, intravenous administration over 24 hours. |
| Name | Type | Description |
|---|---|---|
| TAK-123 | DRUG | TAK-123 infusion |
Inclusion Criteria: 1. The participant is capable of understanding and complying with protocol requirements in the opinion of the investigator or sub-investigator. 2. The participant signs and dates a written informed consent form prior to the initiation of any study procedures. 3. The participant ...
TAK-123 is an investigational small molecule drug being developed by Takeda Pharmaceutical Company Limited. It has been studied in a Phase 1 clinical trial in healthy adult male volunteers in Japan. Takeda has not publicly disclosed the specific disease or condition that TAK-123 is intended to treat.
TAK-123 is made by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the developer responsible for the clinical program evaluating TAK-123, including the Phase 1 pharmacokinetics, safety and tolerability study conducted in Japanese healthy adult male participants.
TAK-123 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. Because only early-stage testing has been conducted, TAK-123 is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
TAK-123 has been evaluated in one completed Phase 1 trial, NCT04155567, titled A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-123 After Intravenous Infusion in Japanese Healthy Adult Male Participants. The trial enrolled 10 healthy male volunteers aged 20 years and older in Japan and used an uncontrolled design.
TAK-123 was given by intravenous infusion in its Phase 1 trial, NCT04155567. That study assessed the pharmacokinetics, safety and tolerability of the drug in 10 Japanese healthy adult male participants. The trial was uncontrolled, was not randomized, and was not double blinded, and it has been completed.