This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single dose administration on the first treatment day (Day 1) and will be assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to 28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at least 5 days but no longer than 7 days after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.
Research Site
Clearwater, Florida, United States
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) - Budesonide
Time frame: Day 1
Maximum Plasma Concentration (Cmax) - Budesonide
Maximum plasma concentration (Cmax) - Budesonide
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) - Glycopyrronium
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum Plasma Concentration (Cmax) - Glycopyrronium
Maximum plasma concentration (Cmax) - Glycopyrronium
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) - Formoterol
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Maximum Plasma Concentration (Cmax) - Formoterol
Maximum plasma concentration (Cmax) - Formoterol
Time frame: Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Budesonide
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Budesonide
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Time frame: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Glycopyrronium
Time frame: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-12) - Formoterol
Area under the plasma concentration-time curve from 0 to 12 hours (AUC 0-12) - Formoterol
Time frame: Day 8
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Budesonide
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Budesonide
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Glycopyrronium
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Glycopyrronium
Time frame: Day 1
Area Under the Plasma Concentration-time Curve (AUC 0-tlast) - Formoterol
Area under the plasma concentration-time curve from 0 to the time of the last measurable plasma concentration (AUC 0-tlast) - Formoterol
Time frame: Day 1
Time to Maximum Plasma Concentration (Tmax) - Budesonide
Time to maximum plasma concentration (tmax) - Budesonide
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium
Time to maximum plasma concentration (tmax) - Glycopyrronium
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Time to Maximum Plasma Concentration (Tmax) - Formoterol
Time to maximum plasma concentration (tmax) - Formoterol
Time frame: Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose), Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Budesonide
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Glycopyrronium
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Formoterol
Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) - Formoterol
Time frame: Day 1