Study to evaluate single inhaled doses of PT001, PT003, PT005 and PT001 Plus PT005 in healthy subjects

Study identifier:PT0030901

ClinicalTrials.gov identifier:NCT00893971

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

PT001, PT005, PT003, PT001 + PT005

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 May 2009

Primary Completion Date: 01 Jul 2009

Study Completion Date: 01 Jul 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2016 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion 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

No locations available

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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Stuart Gibbons

+61(0)7 3331 3933

[email protected]

Contact Backup

Russell Neal