drugset / Trial / NCT06268301

A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults

NCT06268301

Phase 1 Completed 20 enrolled Takeda
RandomizedCrossoverOpen-labelTreatment

Summary

The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition.

Timeline

Start
2023-02-06
Primary completion
2023-02-17
Completion
2023-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Budesonide Small molecule 2 mg Oral

Indications

No indication recorded.