Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

NCT04856098 | Completed Phase 1

• 1 other identifier: 3131001
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• 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

Study Arms (5)

Part 1 Ultibro Breezhaler 2 capsules, Batch A

EXPERIMENTAL

Drug: Indacaterol maleate and glycopyrronium bromide

Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A

EXPERIMENTAL

Drug: Indacaterol maleate and glycopyrronium bromide; Drug: Ultibro Breezhaler with oral charcoal

Part 1 Ultibro Breezhaler 1 capsule, Batch A

EXPERIMENTAL

Drug: Indacaterol maleate and glycopyrronium bromide

Part 2 Ultibro Breezhaler 2 capsules, Batch A

EXPERIMENTAL

Drug: Indacaterol maleate and glycopyrronium bromide

Part 2 Ultibro Breezhaler 2 capsules, Batch B

EXPERIMENTAL

Drug: Indacaterol maleate and glycopyrronium bromide

Interventions

Indacaterol maleate and glycopyrronium bromide DRUG

Batch A Ultibro Breezhaler 85/43 μg 2 capsules

Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A; Part 1 Ultibro Breezhaler 2 capsules, Batch A; Part 2 Ultibro Breezhaler 2 capsules, Batch A

Ultibro Breezhaler with oral charcoal DRUG

Activated charcoal suspension, granules 50 g / bottle

Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females
• years of age
• Body mass index 19-30 kg/m2
• Weight at least 50 kg
• Written informed consent obtained

You may not qualify if:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease
• Any condition requiring regular concomitant treatment
• 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
• Known hypersensitivity to indacaterol or glycopyrronium
• Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
• Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

CRST Helsinki Oy

Helsinki, Finland

Location

MeSH Terms

Interventions

Glycopyrrolate; Charcoal

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbon; Elements; Inorganic Chemicals

Study Officials

• Orion Corporation Clinical Study Director

  Orion Corporation, Orion Pharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 22, 2021
• Study Start: May 7, 2021
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

FI (1)