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

Completed · Phase 1

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID
NCT03250182
Run by
Pearl Therapeutics, Inc.
People needed
30
Starts
2017-08-11
Expected to finish
2017-12-07
Last updated by the study team
2021-01-29

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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