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

Sponsor

Sandoz (Industry)

Overall Status

Completed

CT.gov ID

NCT05429775

Collaborator

(none)

Enrollment

Location

Arms

1.1

Actual Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Budesonide	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 26, 2018

Actual Primary Completion Date :

Jan 29, 2019

Actual Study Completion Date :

Jan 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Budesonide: Formulation 1 single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions	Drug: Budesonide single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Experimental: Budesonide: Formulation 2 single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions	Drug: Budesonide single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Experimental: Budesonide: Formulation 3 single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions	Drug: Budesonide single dose of 2 mg oral suspension formulation administered orally under fasting conditions
Experimental: Budesonide: Formulation 4 single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions	Drug: Budesonide single dose of 2 mg oral suspension formulation administered orally under fasting conditions

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Number of adverse events [throughout the study, approximately 13 weeks]
Number of adverse events will be provided to get additional information on the safety and tolerability of budesonide suspension formulations after oral administration.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy males and females aged 30 to 65 years
Body mass index 18.0 to 32.0 kg/m2

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sandoz Investigative Site	Nottingham	England	United Kingdom	NG11 6JS

Sponsors and Collaborators

Sandoz

Investigators

Study Director: Sandoz, Sandoz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sandoz

ClinicalTrials.gov Identifier:

NCT05429775

Other Study ID Numbers:

SAN-0385/1828-BUD-3

First Posted:

Jun 23, 2022

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Budesonide

Study Results

No Results Posted as of Jun 23, 2022