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Completed

NCT Number: NCT04856098

Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRST Helsinki Oy

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Main inclusion criteria:

  • Healthy males and females
  • 18-60 years of age
  • Body mass index 19-30 kg/m2
  • Weight at least 50 kg
  • Written informed consent obtained

Main exclusion criteria:

  • 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

Treatment and study plan

Indacaterol maleate and glycopyrronium bromide

Drug

Batch A Ultibro Breezhaler 85/43 μg 2 capsules

Ultibro Breezhaler with oral charcoal

Drug

Activated charcoal suspension, granules 50 g / bottle

Primary outcomes

  1. Peak indacaterol concentration in plasma (Cmax)

    Time frame: between 0-72 hours after dosing

  2. Peak glycopyrronium concentration in plasma (Cmax)

    Time frame: between 0-72 hours after dosing

  3. Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min)

    Time frame: 0-30 minutes after dosing

  4. Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min)

    Time frame: 0-30 minutes after dosing

  5. Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h)

    Time frame: 0-72 hours after dosing

  6. Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h)

    Time frame: 0-72 hours after dosing

Secondary outcomes

  1. Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)

    Time frame: 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)

    Time frame: 0-18 days after dosing

  3. Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf)

    Time frame: 0-18 days after dosing

  4. Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf)

    Time frame: 0-18 days after dosing

  5. Time to reach peak indacaterol concentration in plasma

    Time frame: between 0-72 hours after dosing

  6. Time to reach peak glycopyrronium concentration in plasma

    Time frame: between 0-72 hours after dosing

  7. Indacaterol terminal elimination half-life (t1/2)

    Time frame: 0-18 days after dosing

  8. Glycopyrronium terminal elimination half-life (t1/2)

    Time frame: 0-18 days after dosing

  9. Number of adverse events as event counts and subjects counts

    Time frame: throughout the study, average 9-12 weeks

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Acronym: FINDA

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2021
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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