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A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug up to eos (up to 15 days)
Awards & highlights
No Placebo-Only Group
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose of study drug up to eos (up to 15 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug up to eos (up to 15 days)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Events (SAE), and Death
Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values Reported as Adverse Events
Number of Participants With Clinically Significant Abnormal Vital Sign Values Reported as Adverse Events
Side effects data
From 2016 Phase 4 trial • 222 Patients • NCT020553529%
Influenza
9%
Nasopharyngitis
8%
Headache
7%
Dysphonia
6%
Urinary tract infection
6%
Arthralgia
5%
Back pain
2%
Chronic obstructive pulmonary disease
1%
Vascular insufficiency
1%
Venous thrombosis limb
1%
Peripheral arterial occlusive disease
1%
Acute myocardial infarction
1%
Cor pulmonale
1%
Nodal arrhythmia
1%
Pneumonia
1%
Hip fracture
1%
Hepatocellular carcinoma
1%
Acute pulmonary oedema
1%
Bradycardia
1%
Cellulitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone / Salmeterol (B)
Budesonide / Indacaterol (A)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sequence 2: BOS 2 mg Fed, then FastedExperimental Treatment1 Intervention
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).
Group II: Sequence 1: BOS 2 mg Fasted, then FedExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
2017
Completed Phase 4
~13050
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
TakedaLead Sponsor
1,240 Previous Clinical Trials
4,147,657 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,290 Previous Clinical Trials
500,698 Total Patients Enrolled