AsthmaPhase 1BF-BLOCKNCT01423305
Phase I Pharmacokinetic Study (BF-BLOCK)
A Phase 1 study testing Budesonide/formoterol capsule. and Budesonide/formoterol capsule for oral adm. in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/formoterol capsule. and Budesonide/formoterol capsule for oral adm.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2011to Oct 2011
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females aged 18-60 years.
- Normal weight at least 50 kg.
Who cannot join
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- Known hypersensitivity to the active substance(s) or the excipients of the drug.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol capsule., Budesonide/formoterol capsule for oral adm.
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterol capsule.Drug
Oral administration with concomitant charcoal.
Budesonide/formoterol capsule for oral adm.Drug
Oral administration without concomitant charcoal.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Budesonide/formoterol capsule (Orion Pharma) for oral administration. Receives: Drug: Budesonide/formoterol capsule. |
| Treatment B | Experimental | Budesonide/formoterol capsule (Orion Pharma) for oral administration. Receives: Drug: Budesonide/formoterol capsule for oral adm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of primary pharmacokinetic variable AUCt
The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.
Measured: 4 weeks
Secondary outcomes (2)
Pharmacokinetic variables
Cmax
Measured: 4 weeks
Pharmacokinetic variable
tmax
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mika Scheinin, M.D.Ph.D, Principal investigator, Clinical Research Services Turku Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423305
- Sponsor's protocol ID
- 3103008
- Acronym
- BF-BLOCK
- Status last verified
- Oct 2011
- First submitted
- 23 Aug 2011
- Last updated
- 21 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Charcoal on Gastrointestinal Absorption of Budesonide and Formoterol
- ClinicalTrials.gov ID
- NCT01423305
- Acronym / sponsor ID
- BF-BLOCK / 3103008
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Aug 2011 (estimated)
- 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.
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Budesonide/formoterol capsule.Budesonide/formoterol capsule (Orion Pharma) for oral administration. |
| Treatment B | Experimental | Drug: Budesonide/formoterol capsule for oral adm.Budesonide/formoterol capsule (Orion Pharma) for oral administration. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males and females aged 18-60 years.
- Normal weight at least 50 kg.
Key exclusion criteria (5 listed)
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- Known hypersensitivity to the active substance(s) or the excipients of the drug.
- Pregnant or lactating females.
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 |
|---|---|---|
| Budesonide/formoterol capsule.Oral administration with concomitant charcoal. | Drug | Treatment A |
| Budesonide/formoterol capsule for oral adm.Oral administration without concomitant charcoal. | Drug | Treatment B |
Primary outcome
The evaluation of primary pharmacokinetic variable AUCt
Time frame: 4 weeks
The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design.
2 secondary outcomes
Pharmacokinetic variables
Time frame: 4 weeks
Pharmacokinetic variable
Time frame: 4 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 21 Oct 2011.
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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.
Mika Scheinin, M.D.Ph.D principal investigator
Clinical Research Services Turku Finland
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/formoterol capsule. and Budesonide/formoterol capsule for oral adm. in people with Asthma, run by Orion Corporation, Orion Pharma at 1 site in Finland.
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 5 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 21 Oct 2011. 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 Finland. 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?
The evaluation of primary pharmacokinetic variable AUCt (time frame: 4 weeks). 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 21 Oct 2011.