Healthy VolunteersPhase 1FORELLINCT05288075
Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product
A Phase 1 study testing Indacaterol/glycopyrronium in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Indacaterol/glycopyrronium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFinland
- Study dates
- 28 Feb 2022to 27 Jun 2022
- 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
Main Inclusion Criteria:
- Healthy males and females
- 18-60 years of age
- Body mass index 19-30 kg/m2
- Weight at least 50 kg
- Written informed consent obtained
Main Exclusion Criteria:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease
- Any condition requiring regular concomitant treatment
- Any clinically significant abnormal laboratory value, vital sign or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject
- Known hypersensitivity to indacaterol or glycopyrronium
- Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
- Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic Formulation Feasibility Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Easyhaler Test Products and Reference Product Ultibro Breezhaler
This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.
- Conditions
- Healthy Volunteers
- Being tested
- Indacaterol/glycopyrronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indacaterol/glycopyrroniumDrug
Also called Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C with charcoal, Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule with charcoal
In each period, subjects receive single dose of indacaterol/glycopyrronium consisting of 2 inhaled doses via Easyhaler or 2 capsules inhaled via Ultibro Breezhaler.
In addition to study treatments, activated charcoal will be administered on each study period before and after study drug administration.
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A | Experimental | Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant A in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). Receives: Drug: Indacaterol/glycopyrronium |
| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B | Experimental | Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant B in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). Receives: Drug: Indacaterol/glycopyrronium |
| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C | Experimental | Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant C in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). Receives: Drug: Indacaterol/glycopyrronium |
| Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule | Active comparator | Each subject will receive 2 capsules of Ultibro® Breezhaler® (=Indacaterol/glycopyrronium) as a single dose in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). Receives: Drug: Indacaterol/glycopyrronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak indacaterol and glycopyrronium concentration in plasma (Cmax)
Pharmacokinetic parameters of indacaterol and glycopyrronium
Measured: between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 72 hours (AUC72)
Pharmacokinetic parameters of indacaterol and glycopyrronium
Measured: between 0-72 hours after dosing
Secondary outcomes (2)
Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)
Pharmacokinetic parameters of indacaterol and glycopyrronium
Measured: between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 30 minutes (AUC30)
Pharmacokinetic parameters of indacaterol and glycopyrronium
Measured: between 0-30 minutes after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start28 Feb 2022
- Primary completion27 Jun 2022
- Study completion27 Jun 2022
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orion Corporation Clinical Study Director, Study director, Orion Corporation, Orion PharmaClinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288075
- Sponsor's protocol ID
- 3131002
- Acronym
- FORELLI
- Status last verified
- Jul 2022
- First submitted
- 7 Feb 2022
- Last updated
- 13 Jul 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 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Formulation Feasibility Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Easyhaler Test Products and Reference Product Ultibro Breezhaler
- ClinicalTrials.gov ID
- NCT05288075
- Acronym / sponsor ID
- FORELLI / 3131002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 27 Jun 2022 (actual)
- First posted
- 18 Mar 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 formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A | Experimental | Drug: Indacaterol/glycopyrroniumEach subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant A in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B | Experimental | Drug: Indacaterol/glycopyrroniumEach subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant B in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
| Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C | Experimental | Drug: Indacaterol/glycopyrroniumEach subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant C in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
| Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule | Active comparator | Drug: Indacaterol/glycopyrroniumEach subject will receive 2 capsules of Ultibro® Breezhaler® (=Indacaterol/glycopyrronium) as a single dose in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Indacaterol/glycopyrroniumAlso: Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B with charcoal, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C with charcoal, Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule with charcoalIn each period, subjects receive single dose of indacaterol/glycopyrronium consisting of 2 inhaled doses via Easyhaler or 2 capsules inhaled via Ultibro Breezhaler. In addition to study treatments, activated charcoal will be administered on each study period before and after study drug administration. | Drug | Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B, Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C, Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule |
Primary outcome
Peak indacaterol and glycopyrronium concentration in plasma (Cmax)
Time frame: between 0-72 hours after dosing
Pharmacokinetic parameters of indacaterol and glycopyrronium
Area under the concentration-time curve from time zero to 72 hours (AUC72)
Time frame: between 0-72 hours after dosing
Pharmacokinetic parameters of indacaterol and glycopyrronium
2 secondary outcomes
Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)
Time frame: between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 30 minutes (AUC30)
Time frame: between 0-30 minutes after dosing
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 13 Jul 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.
Orion Corporation Clinical Study Director study director
Orion Corporation, Orion Pharma
Clinical Study Director study director
Orion Corporation, Orion Pharma
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 Indacaterol/glycopyrronium in people with Healthy Volunteers, 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?
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 13 Jul 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 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?
Peak indacaterol and glycopyrronium concentration in plasma (Cmax) (time frame: between 0-72 hours after dosing). The study lists 2 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 13 Jul 2022.