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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Study to Assess the Pharmacokinetics and Safety of PT010 in Subjects With Moderate to Severe COPD Following Single and Repeat Dose Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03250182
• Other study ID #: PT010018
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2017
• Est. completion date: December 7, 2017

Study information

• Verified date: January 2021
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Key Inclusion Criteria:

• Given their signed written informed consent to participate.

• Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.

• Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.

• Current or former smokers with a history of at least 10 pack-years of cigarette smoking.

• Pre-bronchodilator FEV1/FVC ratio must be <0.70 and pre-bronchodilator FEV1 must be =50% and <80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations

Key Exclusion Criteria:

• Significant diseases or conditions to : other than COPD, active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease and uncontrolled sleep apnea .

• Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.

• Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.

• Subjects who have a history of hypersensitivity to any corticosteroid,

• ß2-agonist, muscarinic anticholinergic, or any component of the MDI

• Alpha-1 antitrypsin deficiency as the cause of COPD

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.

Locations

Country	Name	City	State
United States	Research Site	Clearwater	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Plasma Concentration (Cmax) - Budesonide	Maximum plasma concentration (Cmax) - Budesonide	Day 1
Primary	Maximum Plasma Concentration (Cmax) - Budesonide	Maximum plasma concentration (Cmax) - Budesonide	Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose
Primary	Maximum Plasma Concentration (Cmax) - Glycopyrronium	Maximum plasma concentration (Cmax) - Glycopyrronium	Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Primary	Maximum Plasma Concentration (Cmax) - Glycopyrronium	Maximum plasma concentration (Cmax) - Glycopyrronium	Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Primary	Maximum Plasma Concentration (Cmax) - Formoterol	Maximum plasma concentration (Cmax) - Formoterol	Day 1 (pre-dose 2,6,20,40 minutes, 1,2,4,8,10,12,18,24 hours post-dose)
Primary	Maximum Plasma Concentration (Cmax) - Formoterol	Maximum plasma concentration (Cmax) - Formoterol	Day 8 (pre-dose and 2,6,20,40 minutes, 1,2,4,8,10,12 hours post-dose)
Primary	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	Day 1
Primary	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	Day 8
Primary	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	Day 1
Primary	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	Day 8
Primary	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	Day 1
Primary	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	Day 8
Primary	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	Day 1
Primary	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	Day 1
Primary	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	Day 1
Secondary	Time to Maximum Plasma Concentration (Tmax) - Budesonide	Time to maximum plasma concentration (tmax) - Budesonide	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)
Secondary	Time to Maximum Plasma Concentration (Tmax) - Glycopyrronium	Time to maximum plasma concentration (tmax) - Glycopyrronium	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)
Secondary	Time to Maximum Plasma Concentration (Tmax) - Formoterol	Time to maximum plasma concentration (tmax) - Formoterol	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)
Secondary	Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-8) - Budesonide	Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-8) - Budesonide	Day 1
Secondary	Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-8) - Glycopyrronium	Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-8) - Glycopyrronium	Day 1
Secondary	Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-8) - Formoterol	Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-8) - Formoterol	Day 1