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Completed

NCT Number: NCT06268301

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 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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Budesonide

Drug

Budesonide oral suspension

Other names: TAK-721

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  2. Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  3. Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

Secondary outcomes

  1. Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death

    Time frame: From first dose of study drug up to the end of study (EOS) (Up to 15 days)

    An adverse event (AE) was 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 (eg, 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 was defined as an adverse event with an onset that occurs after receiving study drug. An SAE was 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.

  2. Number of Participants With Clinically Significant Abnormal Vital Sign Values Reported as Adverse Events

    Time frame: From first dose of study drug up to EOS (Up to 15 days)

    Vital signs included body temperature, respiratory rate, blood pressure, and pulse rate evaluations.

  3. Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values Reported as Adverse Events

    Time frame: From first dose of study drug up to EOS (Up to 15 days)

    Clinical laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.

  4. Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 12 hours) post-dose on Day 1

  5. Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  6. Time to First Occurrence of Cmax (Tmax) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  7. Lag Time to First Quantifiable Concentration (Tlag) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  8. Terminal Disposition Phase Half-life (t1/2z) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  9. Terminal Disposition Phase Rate Constant (λz) of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  10. Apparent Clearance (CL/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

  11. Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS

    Time frame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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