Clinical trial NCT04856098: Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler
Official title: A Pharmacokinetic Feasibility Study on Ultibro Breezhaler, an Indacaterol-glycopyrronium Inhalation Powder Capsule, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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


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

Primary outcomes:
measure: Peak indacaterol concentration in plasma (Cmax)
timeFrame: between 0-72 hours after dosing
measure: Peak glycopyrronium concentration in plasma (Cmax)
timeFrame: between 0-72 hours after dosing
measure: Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min)
timeFrame: 0-30 minutes after dosing
measure: Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min)
timeFrame: 0-30 minutes after dosing
measure: Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h)
timeFrame: 0-72 hours after dosing
measure: Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h)
timeFrame: 0-72 hours after dosing
Secondary outcomes:
measure: Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)
timeFrame: 0-18 days after dosing
measure: Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)
timeFrame: 0-18 days after dosing
measure: Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: 0-18 days after dosing
measure: Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: 0-18 days after dosing
measure: Time to reach peak indacaterol concentration in plasma
timeFrame: between 0-72 hours after dosing
measure: Time to reach peak glycopyrronium concentration in plasma
timeFrame: between 0-72 hours after dosing
measure: Indacaterol terminal elimination half-life (t1/2)
timeFrame: 0-18 days after dosing
measure: Glycopyrronium terminal elimination half-life (t1/2)
timeFrame: 0-18 days after dosing
measure: Number of adverse events as event counts and subjects counts
timeFrame: throughout the study, average 9-12 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: CRST Helsinki Oy
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Orion Corporation Clinical Study Director
role: STUDY_DIRECTOR
References: