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Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893971
First Posted: May 6, 2009
Last Update Posted: April 26, 2017
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.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
  Purpose
The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.

Condition Intervention Phase
Healthy Volunteers Drug: PT001 Drug: PT005 Drug: PT003 Drug: PT001 + PT005 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Single Dose, Four-period, Four-treatment, Cross-over Study Evaluating the Safety of PT001, PT003, PT005 Administered Individually and PT001 + PT005 Delivered Together in Separate Inhalers in Healthy Subjects

Further study details as provided by Pearl Therapeutics, Inc.:

Primary Outcome Measures:
  • Symptoms of Dry Mouth [ Time Frame: 12 hours ]
    Number of participants reporting dry mouth at 12 hours post-dose

  • Symptoms of Tremor [ Time Frame: 12 hours ]
    Number of participants reporting tremor at 12 hours post-dose

  • Blood Chemistry Change From Baseline [ Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects ]
    Series of 11 blood chemistries assessed throughout the study

  • Hematology Change From Baseline [ Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects ]
    Hematology assessments taken throughout the study Hematocrit

  • Hematology Change From Baseline [ Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects ]
    Hematology assessments taken throughout the study

  • Hematology Change From Baseline [ Time Frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects ]
    Hematology assessments taken throughout the study Hemoglobin

  • Heart Rate Change From Baseline [ Time Frame: 12 hours ]
    Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)

  • Vital Sign Change Baseline; Blood Pressure [ Time Frame: 12 hours ]
    Vital sign change baseline; blood pressure

  • Vital Sign Change From Baseline, SpO2 [ Time Frame: 12 hours ]
    Vital Sign Change from baseline 12-hours post-dose SpO2 (%)

  • ECG Change From Baseline [ Time Frame: 12 hours ]
    Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)

  • ECG Change From Baseline [ Time Frame: 12 hours ]
    Change from baseline for ECG parameters 12-hours post-dose

  • Spirometry Change From Baseline [ Time Frame: 12 hours ]
    Change from baseline for spirometery measures 12-hours post-dose

  • Spirometry Change From Baseline [ Time Frame: 12 hours ]
    Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)

  • Spirometry Change From Baseline [ Time Frame: 12 hours ]
    Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)

  • Spirometry Change From Baseline [ Time Frame: 12 hours ]
    Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)

  • Serum Potassium Change From Baseline [ Time Frame: 12 hours ]

Secondary Outcome Measures:
  • Plasma Glycopyrrolate PK Parameters [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma glycopyrrolate

  • Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma glycopyrrolate

  • Plasma Glycopyrrolate PK Parameters (Tmax) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma glycopyrrolate

  • Plasma Glycopyrrolate PK Parameters (t1/2) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma glycopyrrolate

  • Plasma Glycopyrrolate PK Parameters Cmax (pg/mL) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma glycopyrrolate

  • Plasma Glycopyrrolate PK Parameters (ke) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma glycopyrrolate

  • Plasma Formoterol PK Parameters [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma formoterol

  • Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma formoterol

  • Plasma Formoterol PK Parameters (Tmax) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma formoterol

  • Plasma Formoterol PK Parameters (t1/2) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Various pharmacokinetic parameters for plasma formoterol

  • Plasma Formoterol PK Parameters (Cmax) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Pharmacokinetic parameters for plasma formoterol Cmax

  • Plasma Formoterol PK Parameters (ke) [ Time Frame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose ]
    Pharmacokinetic parameters for plasma formoterol ke


Enrollment: 16
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Inhaled PT001 18 μg
Drug: PT001
Inhaled PT001, single dose
Experimental: 2
Inhaled PT005 2.4 μg
Drug: PT005
Inhaled PT005, single dose
Experimental: 3
Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)
Drug: PT003
Inhaled PT003, single dose
Experimental: 4
PT001 18 μg + PT005 2.4 μg
Drug: PT001 + PT005
Inhaled PT001 + PT005, single dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Provide signed written informed consent
  • 18-55 years of age
  • Healthy subjects confirmed by medical history, physical examination, vital signs, pulmonary function tests, electrocardiogram and clinical laboratory tests
  • Female subjects of child-bearing potential who are sexually active must be willing to undergo a pregnancy test and agree to use two forms of contraception
  • Body mass index (BMI) between 18.5 and 30, inclusive
  • Non-smokers for at least 6 months prior to screening
  • Pulmonary function tests within normal limits
  • Willing to remain at the study center for at least 12-24 hours on each test day
  • Venous access in both arms to allow collection of numerous blood samples

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Clinically significant medical conditions
  • Viral illness within the last 30 days
  • Symptomatic prostatic hypertrophy or bladder neck obstruction
  • Known narrow-angle glaucoma
  • History of bowel obstruction
  • Clinically significant abnormal electrocardiogram
  • Positive Hepatitis B surface antigen or positive Hepatitis C antibody
  • Positive screening test for HIV antibodies
  • History of hypersensitivity to any beta2-agonists, anticholinergics, or any component of the MDI
  • Known or suspected history of alcohol or drug abuse within the last 2-years
  • Greater than normal alcohol consumption
  • Ingestion of any poppy seeds within the 48 hours prior to the screening
  • Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines or grapefruit-containing foods or beverages within the 24 hours prior to, or during, each confinement
  • Positive breath alcohol result
  • Positive urine drug screen
  • Use of any beta2-agonists,or anticholinergics prior to the recruitment interview
  • Lower respiratory tract infections requiring antibiotics in the previous 6 weeks
  • Use of any other prescription medication
  • Use of any over the counter product, herbal product, diet aid, hormone supplement
  • Donation > 450 ml of blood within 8 weeks of first treatment dose
  • Clinically significant vital sign abnormality
  • Clinically significant biochemical, hematological or urinalysis abnormality
  • Affiliations with investigator site
  • Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives prior to screening, whichever is longer
  Contacts and Locations
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): NCT00893971


Locations
Australia, Queensland
Dr Joanne Marjason
Herston, Queensland, Australia, 4006
Sponsors and Collaborators
Pearl Therapeutics, Inc.
Investigators
Study Director: Colin Reisner, M.D. Pearl Therapeutics
  More Information

Responsible Party: Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00893971     History of Changes
Other Study ID Numbers: PT0030901
First Submitted: May 5, 2009
First Posted: May 6, 2009
Results First Submitted: May 24, 2016
Results First Posted: April 26, 2017
Last Update Posted: April 26, 2017
Last Verified: March 2017

Keywords provided by Pearl Therapeutics, Inc.:
Healthy Volunteers