Healthy VolunteersPhase 1NCT06268301
A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
A Phase 1 study testing Budesonide in people with Healthy Volunteers, run by Takeda at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 20 Feb 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Budesonide
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called TAK-721
Budesonide oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: BOS 2 mg Fasted, then Fed | Experimental | 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). Receives: Drug: Budesonide |
| Sequence 2: BOS 2 mg Fed, then Fasted | Experimental | 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). Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Secondary outcomes (11)
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death
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.
Measured: From first dose of study drug up to the end of study (EOS) (Up to 15 days)
Number of Participants With Clinically Significant Abnormal Vital Sign Values Reported as Adverse Events
Vital signs included body temperature, respiratory rate, blood pressure, and pulse rate evaluations.
Measured: From first dose of study drug up to EOS (Up to 15 days)
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values Reported as Adverse Events
Clinical laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.
Measured: From first dose of study drug up to EOS (Up to 15 days)
Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 12 hours) post-dose on Day 1
Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Time to First Occurrence of Cmax (Tmax) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Lag Time to First Quantifiable Concentration (Tlag) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Terminal Disposition Phase Half-life (t1/2z) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Terminal Disposition Phase Rate Constant (λz) of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Apparent Clearance (CL/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
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
Measured: Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start6 Feb 2023
- Primary completion17 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268301
- Sponsor's protocol ID
- TAK-721-1003
- Status last verified
- Oct 2024
- First submitted
- 13 Feb 2024
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06268301
- Acronym / sponsor ID
- TAK-721-1003
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Posted 2 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: BOS 2 mg Fasted, then Fed | Experimental | Drug: BudesonideParticipants 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). |
| Sequence 2: BOS 2 mg Fed, then Fasted | Experimental | Drug: BudesonideParticipants 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). |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- Participant is lactose intolerant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudesonideAlso: TAK-721Budesonide oral suspension | Drug | Sequence 1: BOS 2 mg Fasted, then Fed, Sequence 2: BOS 2 mg Fed, then Fasted |
Primary outcome
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
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
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
11 secondary outcomes
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)
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)
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)
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Budesonide in people with Healthy Volunteers, run by Takeda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.