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

Takeda

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06268301

TAK-721-1003

Details and patient eligibility

About

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.

Full description

The drug being tested in this study is called budesonide. Budesonide oral suspension (BOS) is being tested in healthy adult participants. This study will determine whether the absorption of BOS will be altered if taken with food.

The study will enroll approximately 20 patients. The study will consist of two treatment sequences and two periods separated by a washout period of 2 days. Participants will be randomly assigned (by chance, like flipping a fair coin) to one of the two treatment sequences:

Treatment Sequence 1: Participants will receive 2 mg BOS orally on Day 1 of Period 1 in fasted condition (Treatment A). Two days later, participants will receive 2 mg BOS orally on Day 1 of Period 2 in fed condition (Treatment B). Treatment Sequence 2: Participants will receive 2 mg BOS orally on Day 1 of Period 1 in fed condition (Treatment B). Two days later, participants will receive 2 mg BOS orally on Day 1 of Period 2 in fasted condition (Treatment A).

This single center trial will be conducted in the United States. Participation in the study is up to approximately 34 days. Participants will visit the clinic approximately three days after last dose of study drug for a follow-up assessment.

Enrollment: 20 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meters squared (kg/m^2) at the screening visit.

Exclusion criteria

1. Presence of any active infection at the screening visit or check-in.

2. Positive urine drug or alcohol results at the screening visit or check-in.

3. Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.

4. Participant is unable to refrain from or anticipates the use of:

   1. 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.
   2. 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.

5. Participant is lactose intolerant.

6. Donation of blood or significant blood loss within 56 days prior to the first dosing.

7. Plasma donation within 7 days prior to the first dosing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sequence 1: BOS 2 mg Fasted, then Fed

Experimental group

Description:

Participants will receive 2 mg BOS, single dose, orally on Day 1 of Period 1 under fasted condition (Treatment A). Two days later, participants will receive 2 mg BOS single dose, orally on Day 1 of Period 2 under fed condition (Treatment B).

Treatment:

Drug: Budesonide

Sequence 2: BOS 2 mg Fed, then Fasted

Experimental group

Description:

Participants will receive 2 mg BOS, single dose, orally on Day 1 of Period 1 under fed condition (Treatment B). Two days later, participants will receive 2 mg BOS single dose, orally on Day 1 of Period 2 under fasted condition (Treatment A).

Treatment:

Drug: Budesonide