Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | Budesonide oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of BOS | 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 | 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 | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
Not provided
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
Not provided
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.
Not provided
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.
Healthy participants were enrolled to receive budesonide oral suspension (BOS) in either of the 2 treatment sequences Fasted-Fed or Fed-Fasted.
Participants took part in the study at 1 investigative site in the United States from 6 February 2023 to 20 February 2023.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1: BOS 2 mg Fasted, Then Fed | Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fasted condition (Treatment A). After a washout of at least 2 days participants then received 2 mg BOS single dose, orally on Day 1 of Period 2 under fed condition (Treatment B). |
| FG001 | Sequence 2: BOS 2 mg Fed, Then Fasted | Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fed condition (Treatment B). After a washout of at least 2 days participants received 2 mg BOS single dose, orally on Day 1 of Period 2 under fasted condition (Treatment A). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
Safety Set included all participants who received any study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1: BOS 2 mg Fasted, Then Fed | Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fasted condition (Treatment A). After a washout of at least 2 days participants then received 2 mg BOS single dose, orally on Day 1 of Period 2 under fed condition (Treatment B). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Concentration (Cmax) of BOS | Pharmacokinetic (PK) Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms per milliliter (pg/mL) | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
From first dose of study drug up to the EOS (15 days)
Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: BOS 2 mg Fasted | Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fasted condition. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2022 | May 29, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2023 | May 29, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
| NOT COMPLETED |
|
| Sequence 2: BOS 2 mg Fed, Then Fasted |
Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 under fed condition (Treatment B). After a washout of at least 2 days participants received 2 mg BOS single dose, orally on Day 1 of Period 2 under fasted condition (Treatment A). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kilograms per metre square (kg/m^2) |
|
| Height | Mean | Standard Deviation | centimetres (cm) |
|
| Weight | Mean | Standard Deviation | kilograms (kg) |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | picograms*hours per milliliter (pg*h/mL) | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | 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. | Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition. | Posted | Count of Participants | Participants | From first dose of study drug up to the end of study (EOS) (Up to 15 days) |
|
|
|
| Secondary | 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. | Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition. | Posted | Count of Participants | Participants | From first dose of study drug up to EOS (Up to 15 days) |
|
|
|
| Secondary | 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. | Safety Set included all participants who received any study drug. Data is presented per fed or fasted condition. | Posted | Count of Participants | Participants | From first dose of study drug up to EOS (Up to 15 days) |
|
|
|
| Secondary | Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg*h/mL | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 12 hours) post-dose on Day 1 |
|
|
|
| Secondary | Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage of AUC | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | Time to First Occurrence of Cmax (Tmax) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Median | Full Range | hours (h) | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | Lag Time to First Quantifiable Concentration (Tlag) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Median | Full Range | hours | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | Terminal Disposition Phase Half-life (t1/2z) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Median | Full Range | hours | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | Terminal Disposition Phase Rate Constant (λz) of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Median | Full Range | 1/hour | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | Apparent Clearance (CL/F) of BOS Calculated Using the Observed Value of the Last Quantifiable Concentration of BOS | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters per hour (L/h) | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| Secondary | 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 | PK Set included all participants who complied sufficiently with the protocol and displayed an evaluable PK profile. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters (L) | Periods 1 and 2: Pre-dose and at multiple timepoints (up to 24 hours) post-dose on Day 1 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | Treatment B: BOS 2 mg Fed | Participants received 2 mg BOS, single dose, orally on Day 1 of Period 1 or Period 2 under fed condition. | 0 | 20 | 0 | 20 | 5 | 20 |
| Vessel puncture site pain | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Deaths |
|