Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06268301
Other study ID # TAK-721-1003
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 6, 2023
Est. completion date February 20, 2023

Study information

Verified date February 2024
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 20, 2023
Est. primary completion date February 17, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 55 Years
Eligibility 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 Tableā„¢) 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Budesonide
Budesonide oral suspension

Locations

Country Name City State
United States Celerion Lincoln Nebraska

Sponsors (1)

Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Observed Concentration (Cmax) Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Primary 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
Primary Area Under the Concentration-time Curve From Time 0 to Infinity (AUC8) Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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
Secondary Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC8 (AUCextrap%) Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Secondary 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
Secondary 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
Secondary 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
Secondary Terminal Disposition Phase Rate Constant (?z). Period 1 and 2: Days 1 and 2 pre-dose and at multiple timepoints (up to 24 hours) post-dose
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1