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

NCT05288075 | Completed Phase 1

• 1 other identifier: 3131002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Peak indacaterol and glycopyrronium concentration in plasma (Cmax)

  Pharmacokinetic parameters of indacaterol and glycopyrronium

  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

  between 0-72 hours after dosing

Secondary Outcomes (2)

• Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)

  between 0-72 hours after dosing

• Area under the concentration-time curve from time zero to 30 minutes (AUC30)

  between 0-30 minutes after dosing

Other Outcomes (1)

• Adverse events

  Up to 11 weeks

Study Arms (4)

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).

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).

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).

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).

Drug: Indacaterol/glycopyrronium

Interventions

Indacaterol/glycopyrronium DRUG

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.

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females
• years of age
• Body mass index 19-30 kg/m2
• Weight at least 50 kg
• Written informed consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

CRST Helsinki Oy

Helsinki, Finland

Location

MeSH Terms

Interventions

indacaterol; Glycopyrrolate; Charcoal; Hardness

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbon; Elements; Inorganic Chemicals; Mechanical Phenomena; Physical Phenomena

Study Officials

• Orion Corporation Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

• Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Bioanalytical laboratory will be blinded with regard to the sequence of the product administration.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: March 18, 2022
• Study Start: February 28, 2022
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

FI (1)