Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

Healthy Volunteers Clinical Trial

— FINDA  

Official title:

A Pharmacokinetic Feasibility Study on Ultibro Breezhaler, an Indacaterol-glycopyrronium Inhalation Powder Capsule, in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856098
• Other study ID #: 3131001
• Status: Completed
• Phase: Phase 1
• Start date: May 7, 2021
• Est. completion date: September 21, 2021

Study information

• Verified date: September 2021
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 21, 2021
• Est. primary completion date: September 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Indacaterol maleate and glycopyrronium bromide
Batch A Ultibro Breezhaler 85/43 µg 2 capsules
• Indacaterol maleate and glycopyrronium bromide
Batch A Ultibro Breezhaler 85/43 µg 1 capsule
• Indacaterol maleate and glycopyrronium bromide
Batch B Ultibro Breezhaler 85/43 µg 2 capsules
• Ultibro Breezhaler with oral charcoal
Activated charcoal suspension, granules 50 g / bottle

Locations

Country	Name	City	State
Finland	CRST Helsinki Oy	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak indacaterol concentration in plasma (Cmax)		between 0-72 hours after dosing
Primary	Peak glycopyrronium concentration in plasma (Cmax)		between 0-72 hours after dosing
Primary	Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min)		0-30 minutes after dosing
Primary	Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min)		0-30 minutes after dosing
Primary	Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h)		0-72 hours after dosing
Primary	Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h)		0-72 hours after dosing
Secondary	Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)		0-18 days after dosing
Secondary	Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)		0-18 days after dosing
Secondary	Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf)		0-18 days after dosing
Secondary	Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf)		0-18 days after dosing
Secondary	Time to reach peak indacaterol concentration in plasma		between 0-72 hours after dosing
Secondary	Time to reach peak glycopyrronium concentration in plasma		between 0-72 hours after dosing
Secondary	Indacaterol terminal elimination half-life (t1/2)		0-18 days after dosing
Secondary	Glycopyrronium terminal elimination half-life (t1/2)		0-18 days after dosing
Secondary	Number of adverse events as event counts and subjects counts		throughout the study, average 9-12 weeks