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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06268301

Run by

Takeda

People needed

20

Starts

2023-02-06

Expected to finish

2023-02-20

Last updated by the study team

2024-12-02

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting.
• Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meters squared (kg/m\^2) at the screening visit.

You may not qualify if…

• Presence of any active infection at the screening visit or check-in.
• Positive urine drug or alcohol results at the screening visit or check-in.
• Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
• Participant is unable to refrain from or anticipates the use of:
• Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing. Medication listed as part of acceptable birth control methods, hormone replacement therapy, and thyroid hormone replacement medication will be allowed.
• Any drugs known to be moderate or strong inducers of cytochrome P450 (CYP) 3A4 enzymes and/or p-glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (e.g., Flockhart Table™) will be consulted to confirm lack of pharmacokinetic (PK) /pharmacodynamic interaction with the study drug.
• Participant is lactose intolerant.
• Donation of blood or significant blood loss within 56 days prior to the first dosing.
• Plasma donation within 7 days prior to the first dosing.

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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