Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product

NCT05288075 — Phase 1, Completed, 24 participants, Orion Corporation, Orion Pharma

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Pharmacokinetic Formulation Feasibility Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Easyhaler Test Products and Reference Product Ultibro Breezhaler

Registry	NCT05288075, acronym FORELLI
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, basic science
Enrollment	24 (Actual)
Sponsor	Orion Corporation, Orion Pharma (Industry)
Conditions	Healthy Volunteers
Interventions	Indacaterol/glycopyrronium (Drug)
Dates	start 2022-02-28, primary completion 2022-06-27, completion 2022-06-27, first posted 2022-03-18, last updated 2022-07-13
Locations	1 site in Finland

-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. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.

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+Arms and interventions

Arm	Type	Interventions	Description
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A	Experimental	Drug: Indacaterol/glycopyrronium	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).
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B	Experimental	Drug: Indacaterol/glycopyrronium	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).
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C	Experimental	Drug: Indacaterol/glycopyrronium	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).
Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule	Active comparator	Drug: Indacaterol/glycopyrronium	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).

Indacaterol/glycopyrronium (Drug), also known as 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.

+Outcome measures

Primary outcomes

Peak indacaterol and glycopyrronium concentration in plasma (Cmax) [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) [between 0-72 hours after dosing]: Pharmacokinetic parameters of indacaterol and glycopyrronium

Secondary outcomes

Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax) [between 0-72 hours after dosing]: Pharmacokinetic parameters of indacaterol and glycopyrronium
Area under the concentration-time curve from time zero to 30 minutes (AUC30) [between 0-30 minutes after dosing]: Pharmacokinetic parameters of indacaterol and glycopyrronium

Other outcomes

Adverse events [Up to 11 weeks]: Adverse events

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Main Inclusion Criteria:

1. Healthy males and females
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. Written informed consent obtained

Main Exclusion Criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease
2. Any condition requiring regular concomitant treatment
3. 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
4. Known hypersensitivity to indacaterol or glycopyrronium
5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration

+Locations (1)

Facility	City	Country	Status
CRST Helsinki Oy	Helsinki	Finland

+Investigators

Orion Corporation Clinical Study Director, Study director, Orion Corporation, Orion Pharma
Clinical Study Director, Study director, Orion Corporation, Orion Pharma