In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

Study Overview
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Brief Summary
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This is a single centre, open-label, sequential, single dose 4-period crossover, scintigraphic imaging study in healthy male and non-pregnant, non-lactating female subjects.

Detailed Description
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Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. For each treatment period, subjects will be admitted to the clinical unit on the evening prior to IMP administration (Day -1) and will fast overnight for a minimum of 8 h. On the morning of Day 1, subjects will receive IMP in the fasted state and will remain on site until 24 h post-dose. Following Period 2, there will be an interim analysis and review of safety and scintigraphy data from dosed regimens in order to determine which formulations will be used in subsequent periods. A follow-up phone call will take place 3 to 5 days post-final dose to ensure the ongoing wellbeing of the subjects.

Official Title
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A Single Part, Four Period Sequential, Open Label Study Designed to Evaluate the In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females aged 30 to 65 years Body mass index 18.0 to 32.0 kg/m2 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide: Formulation 1<br>single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions | Drug: Budesonide<br>* single dose of 2 mg oral suspension formulation administered orally under fasting conditions<br>|
| Experimental: Budesonide: Formulation 2<br>single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions | Drug: Budesonide<br>* single dose of 2 mg oral suspension formulation administered orally under fasting conditions<br>|
| Experimental: Budesonide: Formulation 3<br>single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions | Drug: Budesonide<br>* single dose of 2 mg oral suspension formulation administered orally under fasting conditions<br>|
| Experimental: Budesonide: Formulation 4<br>single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions | Drug: Budesonide<br>* single dose of 2 mg oral suspension formulation administered orally under fasting conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total oesophageal transit time | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. | During procedure | 
| Time at which 10% radiolabel administered has arrived in the oesophagus from the mouth (T10%) (min) | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. | During procedure | 
| Time at which 50% radiolabel administered has arrived in the oesophagus from the mouth (T50%) (min) | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. | During procedure | 
| Time at which the amount of radiolabel present in the oesophagus peaks (Tmax) (min) | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. | During procedure | 
| Time at which 90% of the radiolabel present at Tmax has left the oesophagus (T90%) (min) | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. | During procedure | 
| Total amount of radiolabel present in the oesophagus and the three regions over time | A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods. | During procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Number of adverse events will be provided to get additional information on the safety and tolerability of budesonide suspension formulations after oral administration. | throughout the study, approximately 13 weeks |