Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

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

Sponsors

Lead Sponsor: Orion Corporation, Orion Pharma

Source Orion Corporation, Orion Pharma
Brief Summary

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

Overall Status Recruiting
Start Date 2021-05-07
Completion Date 2021-09-01
Primary Completion Date 2021-09-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Peak indacaterol concentration in plasma (Cmax) between 0-72 hours after dosing
Peak glycopyrronium concentration in plasma (Cmax) between 0-72 hours after dosing
Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min) 0-30 minutes after dosing
Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min) 0-30 minutes after dosing
Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h) 0-72 hours after dosing
Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h) 0-72 hours after dosing
Secondary Outcome
Measure Time Frame
Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) 0-18 days after dosing
Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt) 0-18 days after dosing
Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf) 0-18 days after dosing
Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf) 0-18 days after dosing
Time to reach peak indacaterol concentration in plasma between 0-72 hours after dosing
Time to reach peak glycopyrronium concentration in plasma between 0-72 hours after dosing
Indacaterol terminal elimination half-life (t1/2) 0-18 days after dosing
Glycopyrronium terminal elimination half-life (t1/2) 0-18 days after dosing
Number of adverse events as event counts and subjects counts throughout the study, average 9-12 weeks
Enrollment 34
Condition
Intervention

Intervention Type: Drug

Intervention Name: Indacaterol maleate and glycopyrronium bromide

Description: Batch A Ultibro Breezhaler 85/43 μg 2 capsules

Intervention Type: Drug

Intervention Name: Indacaterol maleate and glycopyrronium bromide

Description: Batch A Ultibro Breezhaler 85/43 μg 1 capsule

Arm Group Label: Part 1 Ultibro Breezhaler 1 capsule, Batch A

Intervention Type: Drug

Intervention Name: Indacaterol maleate and glycopyrronium bromide

Description: Batch B Ultibro Breezhaler 85/43 μg 2 capsules

Arm Group Label: Part 2 Ultibro Breezhaler 2 capsules, Batch B

Intervention Type: Drug

Intervention Name: Ultibro Breezhaler with oral charcoal

Description: Activated charcoal suspension, granules 50 g / bottle

Arm Group Label: Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

60 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Orion Corporation Clinical Study Director Study Director Orion Corporation, Orion Pharma
Overall Contact

Last Name: Orion Corporation Clinical Study Director

Phone: +35810426

Phone Ext.: 6476

Email: [email protected]

Location
Facility: Status: CRST Helsinki Oy
Location Countries

Finland

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 5
Arm Group

Label: Part 1 Ultibro Breezhaler 2 capsules, Batch A

Type: Experimental

Label: Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A

Type: Experimental

Label: Part 1 Ultibro Breezhaler 1 capsule, Batch A

Type: Experimental

Label: Part 2 Ultibro Breezhaler 2 capsules, Batch A

Type: Experimental

Label: Part 2 Ultibro Breezhaler 2 capsules, Batch B

Type: Experimental

Acronym FINDA
Study Design Info

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.

Primary Purpose: Basic Science

Masking: None (Open Label)

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