Overview

A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose

Status:
Completed
Trial end date:
2017-12-07
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1
Details
Lead Sponsor:
Pearl Therapeutics, Inc.
Treatments:
Budesonide
Formoterol Fumarate
Glycopyrrolate