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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.

Tracking Information
First Submitted Date  ICMJE October 21, 2013
First Posted Date  ICMJE November 11, 2013
Last Update Posted Date April 14, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: BGF MDI (PT010) Dose 1
    BGF MDI Dose 1 taken as 2 inhalations
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2013)
84
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01980615
Other Study ID Numbers  ICMJE PT010001-00
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pearl Therapeutics, Inc.
Study Sponsor  ICMJE Pearl Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Colin Reisner, MD Pearl Therapeutics, Inc.
PRS Account Pearl Therapeutics, Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP