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NCT06268301 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Takeda.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target

NCT06268301: Completed Phase 1 study, sponsored by Takeda.

NCT06268301 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06268301, a Phase 1 study, has completed, sponsored by Takeda.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target

Study 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.

Interventions

  • DRUG Budesonide

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2023-02-06
Est. Completion 2023-02-20
Phase Phase 1
Takeda

408 total trials

What the finished NCT06268301 record still lists

NCT06268301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which Budesonide is the first listed.

NCT06268301 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06268301 about?

NCT06268301 is a clinical study titled "A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults". 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 ei...

What is the current status of trial NCT06268301?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-02-06. Estimated completion is 2023-02-20.

What interventions are being tested in trial NCT06268301?

The interventions under investigation include: Budesonide (DRUG).

Who is sponsoring clinical trial NCT06268301?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06268301's enrollment target sits among peer trials

20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06268301, the US trial registry maintained by the National Library of Medicine. NCT06268301 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.