A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults

NCT06268301 | Completed Phase 1 Results FDA Drug

• 1 other identifier: TAK-721-1003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

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

  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

  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

  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

Study Arms (2)

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).

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).

Drug: Budesonide

Interventions

Budesonide DRUG

Budesonide oral suspension

Also known as: TAK-721

Sequence 1: BOS 2 mg Fasted, then Fed; Sequence 2: BOS 2 mg Fed, then Fasted

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Links

• To obtain more information on the study, click here/on this link.

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: February 6, 2023
• Primary Completion: February 17, 2023
• Study Completion: February 20, 2023
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: 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.

Locations

US (1)