NCT01980615

Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers

A Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Pearl Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure \[pharmacokinetics (PK)\] to budesonide following administration of Symbicort MDI.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Inhaled BGF (PT010) Dose 1
DRUG	Inhaled BGF (PT010) Dose 2
DRUG	Inhaled BGF (PT010) Dose 3
DRUG	Inhaled GFF (PT003)
DRUG	Inhaled Symbicort Dose 1
DRUG	Inhaled Symbicort Dose 2

Timeline

• Start date: 2013-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-11-11
• Last updated: 2014-04-14

Locations

1 site across 1 country: United States