Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler (FINDA)

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Indacaterol maleate and glycopyrronium bromide; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: Indacaterol maleate and glycopyrronium bromide; Drug: Ultibro Breezhaler with oral charcoal

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • CRST Helsinki Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

5

Arms and Interventions

Participant Group / 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; Drug: Indacaterol maleate and glycopyrronium bromide; Batch A Ultibro Breezhaler 85/43 μg 1 capsule; Drug: Indacaterol maleate and glycopyrronium bromide; Batch B 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: Indacaterol maleate and glycopyrronium bromide; Batch A Ultibro Breezhaler 85/43 μg 1 capsule; Drug: Indacaterol maleate and glycopyrronium bromide; Batch B 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 2 capsules; Drug: Indacaterol maleate and glycopyrronium bromide; Batch A Ultibro Breezhaler 85/43 μg 1 capsule; Drug: Indacaterol maleate and glycopyrronium bromide; Batch B Ultibro Breezhaler 85/43 μg 2 capsules
EXPERIMENTAL: Part 2 Ultibro Breezhaler 2 capsules, Batch A	Drug: Indacaterol maleate and glycopyrronium bromide; Batch A Ultibro Breezhaler 85/43 μg 2 capsules; Drug: Indacaterol maleate and glycopyrronium bromide; Batch A Ultibro Breezhaler 85/43 μg 1 capsule; Drug: Indacaterol maleate and glycopyrronium bromide; Batch B Ultibro Breezhaler 85/43 μg 2 capsules
EXPERIMENTAL: Part 2 Ultibro Breezhaler 2 capsules, Batch B	Drug: Indacaterol maleate and glycopyrronium bromide; Batch A Ultibro Breezhaler 85/43 μg 2 capsules; Drug: Indacaterol maleate and glycopyrronium bromide; Batch A Ultibro Breezhaler 85/43 μg 1 capsule; Drug: Indacaterol maleate and glycopyrronium bromide; Batch B Ultibro Breezhaler 85/43 μg 2 capsules

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: Orion Corporation, Orion Pharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 7, 2021
• Primary Completion (ACTUAL): September 21, 2021
• Study Completion (ACTUAL): September 21, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (ACTUAL): April 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Protective Agents; Adjuvants, Anesthesia; Anticonvulsants; Antidotes; Maleic acid; Glycopyrrolate; Bromides; Charcoal
• Other Study ID Numbers: 3131001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No