Description Module

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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: 2025-12-24 @ 11:16 PM
Ignite Modification Date: 2025-12-24 @ 11:16 PM
NCT ID: NCT05818956
Brief Summary: The main aim of this study is to test the effects of food consumption with sponsor compound TAK-227 in healthy participants. The study will also measure side effects, and to check how much TAK-227 stays in the blood over time to work out the best dose.
Detailed Description: The drug being tested in this study is called TAK-227. This study will assess the effect of food on single-dose of TAK-227 in healthy participants. The study will enroll approximately 24 participants. A single dose of 50 milligram (mg) TAK-227 will be administered orally under one of 3 different feeding conditions. * Fasting (Treatment A), * Fed following a high-fat or high-calorie meal prior to dosing (Treatment B), and * Fed following a high-fat or high-calorie meal after dosing (Treatment C) Participants will be randomly assigned to 1 of the 6 treatments sequences based on the 3 feeding conditions. * Sequence 1: (Treatment A + Treatment B + Treatment C) * Sequence 2: (Treatment B + Treatment C + Treatment A) * Sequence 3: (Treatment C + Treatment A + Treatment B) * Sequence 4: (Treatment A + Treatment C + Treatment B) * Sequence 5: (Treatment B + Treatment A + Treatment C) * Sequence 6: (Treatment C + Treatment B + Treatment A) All participants will receive all 6 treatment regimens. This is a single-center trial. Participants will be followed up for up to 7 days after the last dose of study drug for a follow-up assessment. The overall time to participate in this study is approximately 40 days including screening period and follow-up period.
Study: NCT05818956
Study Brief:
Protocol Section: NCT05818956