Status:
COMPLETED
Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 singl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00893971
Start Date
May 1 2009
End Date
July 1 2009
Last Update
April 26 2017
Active Locations (1)
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1
Dr Joanne Marjason
Herston, Queensland, Australia, 4006