A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate

Summary

This study is a 2 treatment period, single dose crossover, gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler. This study will be investigating how the drug (known as PT010) is distributed in the lungs following a 10 second or 3 second breath hold. The study will involve the following visits: 1 screening visits, 2 treatment visits, each separated by around 7 days (each with 1 overnight stay; from the evening before dosing until a minimum of 4 hours post-dose on the morning of Day 1) and a post-study follow up phone call. The study population will be 10 healthy males, aged between 28 and 50 years of age.

Timeline

Start

2018-09-04

Primary completion

2018-10-11

Completion

2018-10-11

Drugs

Indications