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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00893971
• Other study ID #: PT0030901
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2009
• Last updated: October 13, 2010
• Start date: May 2009
• Est. completion date: July 2009

Study information

• Verified date: October 2010
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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 single doses in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PT001
Inhaled PT001, single dose
• PT005
Inhaled PT005, single dose
• PT003
Inhaled PT003, single dose
• PT001 + PT005
Inhaled PT001 + PT005, single dose

Locations

Country	Name	City	State
Australia	Dr Joanne Marjason	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of PT003 compared with PT001 and PT005, and compared with PT001 + PT005 delivered together in two separate inhalers		12-hours following study drug administration	Yes
Secondary	Pharmacokinetics of PT003, PT001 and PT005 and PT001 + PT005 from separate inhalers		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	No