Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT04155567
Brief Summary:
The purpose of this study is to evaluate the PK, safety and tolerability of phenylacetate and benzoate after intravenous administration of TAK-123 in Japanese healthy adult male participants.
Detailed Description:
The drug being tested in this study is called TAK-123. TAK-123 is being tested in Japanese healthy adult men. This study will look at the PK, safety and tolerability of phenylacetate and benzoates of people who administered TAK-123.
The study will enroll approximately 10 participants. All participants will be administered TAK-123 intravenously at the dose level of 3.75 g/m\^2 of sodium phenylacetate and 3.75 g/m\^2 of sodium benzoate.
\- TAK-123 as 3.75 g/m\^2 of sodium phenylacetate and 3.75 g/m\^2 of sodium benzoate
This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 8 days. Participants will make multiple visits to the clinic and be hospitalized for four days.
Study:
NCT04155567
Study Brief:
Protocol Section:
NCT04155567