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Trial record 49 of 185 for:    GLYCOPYRROLATE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03250182
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: PT010 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 11, 2017
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol per protocol. Administered as 2 inhalations per use as instructed in the protocol.
Drug: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.
Other Name: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: Day 1 and Day 8 ]
  2. Area under the plasma concentration-time curve from 0 to 12 hours (AUC0-12) [ Time Frame: Day 1 and Day 8 ]
  3. Area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-tlast) [ Time Frame: Day 1 and Day 8 ]

Secondary Outcome Measures :
  1. Time to maximum plasma concentration (tmax) [ Time Frame: Day 1 and Day 8 ]
    Pharmacokinetics of BGF MDI will be assessed using plasma concentrations of budesonide, glycopyrronium, and formoterol

  2. Area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: Day 1 and Day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250182


Locations
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United States, Florida
Pearl Investigative Site
Clearwater, Florida, United States, 33765
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Director: Paul M Dorinnsky, MD Pearl Therapeutics, Inc.

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03250182     History of Changes
Other Study ID Numbers: PT010018
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glycopyrrolate
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Budesonide
Formoterol Fumarate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents