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

NCT03250182 | Completed Phase 1 Results FDA Drug

• 1 other identifier: PT010018
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (15)

• Maximum Plasma Concentration (Cmax) - Budesonide

  Maximum plasma concentration (Cmax) - Budesonide

  Day 1

• 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

• 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)

• 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)

• 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)

• 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)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• 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)

• 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)

• 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)

• Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Budesonide

  Day 1

• Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞) - Glycopyrronium

  Day 1

Study Arms (1)

PT010

EXPERIMENTAL

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

Drug: PT010

Interventions

PT010 DRUG

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

Also known as: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol

PT010

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• β2-agonist, muscarinic anticholinergic, or any component of the MDI
• Alpha-1 antitrypsin deficiency as the cause of COPD

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (1)

Research Site

Clearwater, Florida, 33765, United States

Location

Related Publications (1)

• Dunn LJ, Kerwin EM, DeAngelis K, Darken P, Gillen M, Dorinsky P. Pharmacokinetics of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler formulated using co-suspension delivery technology after single and chronic dosing in patients with COPD. Pulm Pharmacol Ther. 2020 Feb;60:101873. doi: 10.1016/j.pupt.2019.101873. Epub 2019 Dec 10.

  PMID: 31841699 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pearl Therapeutics, Inc.
• Organization: Pearl Therapeutics, Inc.

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Paul M Dorinsky, MD

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: August 11, 2017
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: January 29, 2021
• Results First Posted: May 8, 2020

Record last verified: 2021-01

Locations

US (1)