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Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01980615
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : April 14, 2014
Sponsor:
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.

Brief Summary:
This is a Phase I, Randomized, Double-Blind Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers. The primary objective of the study is to determine a dose of budesonide that when formulated with glycopyrronium and formoterol fumarate in BGF MDI provides comparable systemic exposure [pharmacokinetics (PK)] to budesonide following administration of Symbicort MDI.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Inhaled BGF (PT010) Dose 1 Drug: Inhaled BGF (PT010) Dose 2 Drug: Inhaled BGF (PT010) Dose 3 Drug: Inhaled GFF (PT003) Drug: Inhaled Symbicort Dose 1 Drug: Inhaled Symbicort Dose 2 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 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 Within Device, Single-Dose, Four-Period, Six-Treatment, Cross-Over Study Evaluating the Safety and Pharmacokinetics of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort® Inhalation Aerosol in Healthy Volunteers
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BGF MDI (PT010) Dose 1
BGF MDI Dose 1 taken as 2 inhalations
Drug: Inhaled BGF (PT010) Dose 2
Drug: Inhaled BGF (PT010) Dose 3
Drug: Inhaled GFF (PT003)
Drug: Inhaled Symbicort Dose 1
Drug: Inhaled Symbicort Dose 2
Experimental: BGF MDI (PT010) Dose 2
BGF MDI Dose 2 taken as 2 inhalations
Drug: Inhaled BGF (PT010) Dose 1
Drug: Inhaled BGF (PT010) Dose 3
Drug: Inhaled GFF (PT003)
Drug: Inhaled Symbicort Dose 1
Drug: Inhaled Symbicort Dose 2
Experimental: BGF MDI (PT010) Dose 3
BGF MDI Dose 3 taken as 2 inhalations
Drug: Inhaled BGF (PT010) Dose 1
Drug: Inhaled BGF (PT010) Dose 2
Drug: Inhaled GFF (PT003)
Drug: Inhaled Symbicort Dose 1
Drug: Inhaled Symbicort Dose 2
Active Comparator: GFF MDI (PT003)
GFF MDI (PT003) taken as 2 inhalations
Drug: Inhaled BGF (PT010) Dose 1
Drug: Inhaled BGF (PT010) Dose 2
Drug: Inhaled BGF (PT010) Dose 3
Drug: Inhaled Symbicort Dose 1
Drug: Inhaled Symbicort Dose 2
Active Comparator: Symbicort MDI Dose 1
Symbicort MDI taken as 2 inhalations
Drug: Inhaled BGF (PT010) Dose 1
Drug: Inhaled BGF (PT010) Dose 2
Drug: Inhaled BGF (PT010) Dose 3
Drug: Inhaled GFF (PT003)
Drug: Inhaled Symbicort Dose 2
Active Comparator: Symbicort MDI Dose 2
Symbicort MDI Dose 2 taken as 2 inhalations
Drug: Inhaled BGF (PT010) Dose 1
Drug: Inhaled BGF (PT010) Dose 2
Drug: Inhaled BGF (PT010) Dose 3
Drug: Inhaled GFF (PT003)
Drug: Inhaled Symbicort Dose 1



Primary Outcome Measures :
  1. Overall safety of BGF, GFF, and Symbicort MDI based on the group of outcome measures for safety. [ Time Frame: 12 hours following study drug administration ]

    Safety of Three Doses of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), One Dose of Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (GFF MDI), and Two Doses of Symbicort Inhalation Aerosol.

    The safety of BGF MDI, Symbicort MDI and GFF MDI will be assessed from physical examination findings, adverse event (AE) reporting including SAE reporting, vital signs (blood pressure, heart rate, respiratory rate and body temperature), clinical laboratory values (hematology, biochemistry, and urinalysis), and findings from 12-lead safety electrocardiograms (ECGs).



Secondary Outcome Measures :
  1. Overall pharmacokinetic profile of BGF, GFF, and Symbicort MDI based on the group of outcome measures for pharmacokinetics. [ Time Frame: 12 hours following study drug administration ]

    Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI), Symbicort MDI and GFF MDI.

    The PK of BGF MDI, Symbicort MDI and GFF MDI will be assessed and compared from plasma concentrations of each drug.

    PK parameters at all doses will include Cmax, tmax, t½, AUC0-12, AUC0-t, CL/F, Vd/F, and λz. Other PK parameters may be calculated, as appropriate.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provide signed written informed consent form
  • 18 and 45 years (inclusive)
  • Healthy subject confirmed by a thorough medical history and physical examination, ECG, vital signs and clinical laboratory tests
  • Females of childbearing potential and males with female partners of childbearing potential must agree to use medically acceptable contraception
  • Body mass index (BMI) between 18.5 and 32 kg/m2 (inclusive) and a minimum weight of 50 kg at the screening visit
  • Results of complete laboratory analyses should be within the normal range or determined to be not clinically significant by the Investigator

Exclusion Criteria:

  • Pregnancy, nursing female subjects, or subjects trying to conceive
  • Clinically significant medical conditions
  • History of ECG abnormalities
  • Symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
  • Known diagnosis of glaucoma
  • Known or suspected history of substance-related disorders within 1 year of screening
  • Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) prior to screening period
  • Hypersensitivity to lactose or any drug or component of the formulation(s) used in this study
  • Positive screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or positive hepatitis C antibody at screening.
  • Major surgery within four weeks or minor surgery within 2 weeks of drug administration
  • Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for study participation

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): NCT01980615


Locations
United States, Maryland
Pearl Therapeutics Study Site
Baltimore, Maryland, United States
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Chair: Colin Reisner, MD Pearl Therapeutics, Inc.

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01980615     History of Changes
Other Study ID Numbers: PT010001-00
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: April 14, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists