FINDA: Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

• Sponsor: Orion Corporation, Orion Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04856098
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 5
• Actual Duration (Months): 4.5
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Indacaterol maleate and glycopyrronium bromide; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: Ultibro Breezhaler with oral charcoal	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The study is a 2-part crossover study where the study subjects participate either in part 1 (18 subjects) or in part 2 (16 subjects). The parts can run in sequence or in parallel. The study subjects in part 1 receive single doses of Ultibro Breezhaler on 3 periods and the study subjects in part 2 receive single doses of Ultibro Breezhaler on 2 periods.The study is a 2-part crossover study where the study subjects participate either in part 1 (18 subjects) or in part 2 (16 subjects). The parts can run in sequence or in parallel. The study subjects in part 1 receive single doses of Ultibro Breezhaler on 3 periods and the study subjects in part 2 receive single doses of Ultibro Breezhaler on 2 periods.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Pharmacokinetic Feasibility Study on Ultibro Breezhaler, an Indacaterol-glycopyrronium Inhalation Powder Capsule, in Healthy Subjects
• Actual Study Start Date: May 7, 2021
• Actual Primary Completion Date: Sep 21, 2021
• Actual Study Completion Date: Sep 21, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Peak indacaterol concentration in plasma (Cmax) [between 0-72 hours after dosing]

2. Peak glycopyrronium concentration in plasma (Cmax) [between 0-72 hours after dosing]

3. Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min) [0-30 minutes after dosing]

4. Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min) [0-30 minutes after dosing]

5. Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h) [0-72 hours after dosing]

6. Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h) [0-72 hours after dosing]

Secondary Outcome Measures

1. Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) [0-18 days after dosing]

2. Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) [0-18 days after dosing]

3. Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf) [0-18 days after dosing]

4. Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf) [0-18 days after dosing]

5. Time to reach peak indacaterol concentration in plasma [between 0-72 hours after dosing]

6. Time to reach peak glycopyrronium concentration in plasma [between 0-72 hours after dosing]

7. Indacaterol terminal elimination half-life (t1/2) [0-18 days after dosing]

8. Glycopyrronium terminal elimination half-life (t1/2) [0-18 days after dosing]

9. Number of adverse events as event counts and subjects counts [throughout the study, average 9-12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRST Helsinki Oy	Helsinki		Finland

Sponsors and Collaborators

• Orion Corporation, Orion Pharma

Investigators

• Study Director: Orion Corporation Clinical Study Director, Orion Corporation, Orion Pharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Orion Corporation, Orion Pharma
• ClinicalTrials.gov Identifier: NCT04856098
• Other Study ID Numbers: 3131001
• First Posted: Apr 22, 2021
• Last Update Posted: Sep 28, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glycopyrrolate; Bromides; Maleic acid; Charcoal

Study Results

No Results Posted as of Sep 28, 2021