NCT02512302

Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).

A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sunovion Respiratory Development Inc. · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to determine the amount of medicine absorbed in the lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description

This is a randomized, open-label, single-dose per dosing period, five-way crossover study in subjects 40 to 70 years of age with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines. After a subject provides consent for study participation, there will be a Screening Period lasting up to 3 weeks to determine study eligibility and to allow for appropriate washout of prohibited medications. Eligible subjects will be randomized to one of 10 treatment Sequences. There will be a minimum of a 7-day washout period between each treatment visit. At each visit, subjects will receive one dose of study medication according to the sequence assigned. Subjects with a ≥ 20% decrease in forced expiratory volume in one second (FEV1) based on review of the Visit predose value compared with the Screening value will be evaluated by the investigator for continuation in the study. Subjects taking theophylline will not be able to participate in the study.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	SUN-101 via eFlow nebulizer	50 mcg glycopyrrolate via Electronic Nebulizer
DRUG	SUN-101 via eFlow nebulizer with activated charcoal	50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal
DRUG	Seebri® Breezhaler®	63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
DRUG	Seebri® Breezhaler® with activated charcoal	63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal
DRUG	Glycopyrrolate Injection	50 mcg glycopyrrolate via IV

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2015-07-30
• Last updated: 2018-10-25
• Results posted: 2018-09-14

Locations

2 sites across 1 country: United Kingdom