Healthy VolunteersPhase 1NCT05429775
In Vivo Performance of Oral Liquid Formulations of Budesonide in the Fasted State in Healthy Subjects
A Phase 1 study testing Budesonide in people with Healthy Volunteers, run by Sandoz at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Dec 2018to 29 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females aged 30 to 65 years
- Body mass index 18.0 to 32.0 kg/m2
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sandoz Investigative Site
Nottingham, England, NG11 6JS
About this study
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
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Budesonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
single dose of 2 mg oral suspension formulation administered orally under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| Budesonide: Formulation 1 | Experimental | single dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions Receives: Drug: Budesonide |
| Budesonide: Formulation 2 | Experimental | single dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions Receives: Drug: Budesonide |
| Budesonide: Formulation 3 | Experimental | single dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions Receives: Drug: Budesonide |
| Budesonide: Formulation 4 | Experimental | single dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total oesophageal transit time
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During procedure
Secondary outcomes (1)
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.
Measured: throughout the study, approximately 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start26 Dec 2018
- Primary completion29 Jan 2019
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429775
- Sponsor's protocol ID
- SAN-0385/1828-BUD-3
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05429775
- Acronym / sponsor ID
- SAN-0385/1828-BUD-3
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 26 Dec 2018 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Budesonide: Formulation 1 | Experimental | Drug: Budesonidesingle dose of 2 mg oral suspension formulation 1 administered orally under fasting conditions |
| Budesonide: Formulation 2 | Experimental | Drug: Budesonidesingle dose of 2 mg oral suspension formulation 2 administered orally under fasting conditions |
| Budesonide: Formulation 3 | Experimental | Drug: Budesonidesingle dose of 2 mg oral suspension formulation 3 administered orally under fasting conditions |
| Budesonide: Formulation 4 | Experimental | Drug: Budesonidesingle dose of 2 mg oral suspension formulation 4 administered orally under fasting conditions |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males and females aged 30 to 65 years
- Body mass index 18.0 to 32.0 kg/m2
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonidesingle dose of 2 mg oral suspension formulation administered orally under fasting conditions | Drug | Budesonide: Formulation 1, Budesonide: Formulation 2, Budesonide: Formulation 3, Budesonide: Formulation 4 |
Primary outcome
Total oesophageal transit time
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: During procedure
A comparison of the in vivo oesophageal transit times of budesonide suspension formulations will be determined using scintigraphic methods.
1 secondary outcome
Number of adverse events
Time frame: throughout the study, approximately 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz study director
Sandoz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Budesonide in people with Healthy Volunteers, run by Sandoz at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total oesophageal transit time (time frame: During procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.