Clinical trial NCT06268301: A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Secondary outcomes:
measure: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death
timeFrame: From first dose of study drug up to the end of study (EOS) (Up to 15 days)
measure: Number of Participants With Clinically Significant Abnormal Vital Sign Values Reported as Adverse Events
timeFrame: From first dose of study drug up to EOS (Up to 15 days)
measure: Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values Reported as Adverse Events
timeFrame: From first dose of study drug up to EOS (Up to 15 days)
measure: Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 12 hours) post-dose on Day 1
measure: Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: Time to First Occurrence of Cmax (Tmax) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: Lag Time to First Quantifiable Concentration (Tlag) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: Terminal Disposition Phase Half-life (t1/2z) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: Terminal Disposition Phase Rate Constant (λz) of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: Apparent Clearance (CL/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
measure: 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
timeFrame: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: