Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00893971
First received: May 5, 2009
Last updated: October 13, 2010
Last verified: October 2010
History of Changes

May 5, 2009
October 13, 2010
May 2009
July 2009   (final data collection date for primary outcome measure)
Safety of PT003 compared with PT001 and PT005, and compared with PT001 + PT005 delivered together in two separate inhalers [ Time Frame: 12-hours following study drug administration ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00893971 on ClinicalTrials.gov Archive Site
Pharmacokinetics of PT003, PT001 and PT005 and PT001 + PT005 from separate inhalers [ Time Frame: Immediately prior to study drug administration and at 2, 5, 10, 15, 30 minutes as well as 1, 1.5, 2, 3, 4, 6, 8, 10 and 12 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects
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

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteers
  • Drug: PT001
    Inhaled PT001, single dose
  • Drug: PT005
    Inhaled PT005, single dose
  • Drug: PT003
    Inhaled PT003, single dose
  • Drug: PT001 + PT005
    Inhaled PT001 + PT005, single dose
  • Experimental: 1
    Inhaled PT001 18 μg
    Intervention: Drug: PT001
  • Experimental: 2
    Inhaled PT005 2.4 μg
    Intervention: Drug: PT005
  • Experimental: 3
    Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)
    Intervention: Drug: PT003
  • Experimental: 4
    PT001 18 μg + PT005 2.4 μg
    Intervention: Drug: PT001 + PT005
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2009
July 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00893971
PT0030901
No
Colin Reisner, M.D./Chief Medical Officer, Pearl Therapeutics, Inc
Pearl Therapeutics, Inc.
Not Provided
Study Director: Colin Reisner, M.D. Pearl Therapeutics
Pearl Therapeutics, Inc.
October 2010

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