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Trial record 69 of 186 for:    GLYCOPYRROLATE

Pharmacokinetics and Safety Study of PT010 in Healthy Subjects

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: NCT02189304
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.

Condition or disease Intervention/treatment Phase
COPD Drug: PT010 Drug: PT009 Drug: Symbicort Turbohaler Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects
Actual Study Start Date : June 1, 2014
Actual Primary Completion Date : September 1, 2014
Actual Study Completion Date : September 1, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Drug: PT009
PT009 administered as 2 inhalations
Other Name: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations

Drug: Symbicort Turbohaler
Symbicort Turbohaler taken as 2 inhalations
Other Name: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder

Experimental: PT009
PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Drug: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Other Name: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol

Drug: Symbicort Turbohaler
Symbicort Turbohaler taken as 2 inhalations
Other Name: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder

Active Comparator: Symbicort Turbohaler
Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
Drug: PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Other Name: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol

Drug: PT009
PT009 administered as 2 inhalations
Other Name: PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations




Primary Outcome Measures :
  1. Overall Safety of PT010, PT009 and Symbicort Turbohaler [ Time Frame: 12 hours post dose ]
    The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram


Secondary Outcome Measures :
  1. ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  2. ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  3. ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  4. ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  5. ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  6. ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  7. ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  8. ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  9. ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed Consent Form (ICF) prior to any study related procedures
  • Male and female subjects 18 to 55 years, inclusive
  • Good general health
  • Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
  • Clinical labs within normal ranges or determined to be not clinically significant by the Investigator

Exclusion Criteria:

  • Pregnancy, nursing female subjects, or subjects trying to conceive
  • Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
  • History of ECG abnormalities
  • Cancer not in complete remission for at least 5 years
  • Clinically significant, symptomatic prostatic hypertrophy
  • Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
  • Clinically significant bladder neck obstruction or urinary retention
  • Inadequately treated glaucoma
  • History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
  • Subjects with pre-existing anemia and/or iron deficiency

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): NCT02189304


Locations
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United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
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Study Chair: Chadwick Orevillo Pearl Therapeutics

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Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02189304     History of Changes
Other Study ID Numbers: PT010002-00
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pearl Therapeutics, Inc.:
Healthy volunteers
Additional relevant MeSH terms:
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Glycopyrrolate
Budesonide
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
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