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

A Randomized, Open-Label, Single-Dose, Two-Way Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Budesonide Oral Suspension in Healthy Adult Participants

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Budesonide

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: BOS 2 mg Fasted, then Fed; 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).	Drug: Budesonide; Budesonide oral suspension; Other Names: TAK-721
Experimental: Sequence 2: BOS 2 mg Fed, then Fasted; 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).	Drug: Budesonide; Budesonide oral suspension; Other Names: TAK-721

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Concentration (Cmax)	Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)	Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞)	Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) by Severity, Serious Adverse Events (SAE) and Death	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs for a non-specified period of time after receiving study drug. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that may require an intervention to prevent above items and expose the participant to danger.	From screening up to the end of study (EOS) (Up to approximately 34 days)
Number of Participants With Clinically Significant Abnormal Vital Sign Values	Vital signs will include body temperature, respiratory rate, blood pressure, and pulse rate evaluations.	From screening up to EOS (Up to approximately 34 days)
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values	Clinical laboratory parameters will include hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.	From screening up to EOS (Up to approximately 34 days)
Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12)		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 12 hours) post-dose
Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%)		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Time to First Occurrence of Cmax (tmax)		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Lag Time to First Quantifiable Concentration (tlag)		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Terminal Disposition Phase Half-life (t1/2z)		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Terminal Disposition Phase Rate Constant (λz).		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Apparent Clearance (CL/F) Calculated Using the Observed Value of the Last Quantifiable Concentration		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) Calculated Using the Observed Value of the Last Quantifiable Concentration		Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide
• Other Study ID Numbers: TAK-721-1003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No