Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

Tracking Information
First Submitted Date  ICMJE July 9, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date June 13, 2018
Actual Study Start Date  ICMJE June 1, 2014
Actual Primary Completion Date September 1, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
  • ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  • ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  • ◦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 ]
  • ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  • ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  • ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  • ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  • ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
  • ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler [ Time Frame: 12 Hour post dose ]
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 Pharmacokinetics and Safety Study of PT010 in Healthy Subjects
Official Title  ICMJE 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
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.
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 COPD
Intervention  ICMJE
  • 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
  • Drug: Symbicort Turbohaler
    Symbicort Turbohaler taken as 2 inhalations
    Other Name: Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder
Study Arms  ICMJE
  • Experimental: PT010
    PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
    Interventions:
    • Drug: PT009
    • Drug: Symbicort Turbohaler
  • Experimental: PT009
    PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
    Interventions:
    • Drug: PT010
    • Drug: Symbicort Turbohaler
  • Active Comparator: Symbicort Turbohaler
    Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
    Interventions:
    • Drug: PT010
    • Drug: PT009
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: June 11, 2018)
59
Original Estimated Enrollment  ICMJE
 (submitted: July 10, 2014)
60
Actual Study Completion Date  ICMJE September 1, 2014
Actual Primary Completion Date September 1, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 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 NCT02189304
Other Study ID Numbers  ICMJE PT010002-00
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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: Chadwick Orevillo Pearl Therapeutics
PRS Account Pearl Therapeutics, Inc.
Verification Date June 2018

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