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

NCT ID: NCT00893971

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-07-31

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 single doses in healthy subjects.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Inhaled PT001 18 μg

Group Type: EXPERIMENTAL

PT001

Intervention Type: DRUG

Inhaled PT001, single dose

2

Inhaled PT005 2.4 μg

Group Type: EXPERIMENTAL

PT005

Intervention Type: DRUG

Inhaled PT005, single dose

3

Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)

Group Type: EXPERIMENTAL

PT003

Intervention Type: DRUG

Inhaled PT003, single dose

4

PT001 18 μg + PT005 2.4 μg

Group Type: EXPERIMENTAL

PT001 + PT005

Intervention Type: DRUG

Inhaled PT001 + PT005, single dose

Interventions

PT001

Inhaled PT001, single dose

Intervention Type: DRUG

PT005

Inhaled PT005, single dose

Intervention Type: DRUG

PT003

Inhaled PT003, single dose

Intervention Type: DRUG

PT001 + PT005

Inhaled PT001 + PT005, single dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin Reisner, M.D.

Role: STUDY_DIRECTOR

Pearl Therapeutics

Locations

Dr Joanne Marjason

Herston, Queensland, Australia

Countries

Australia

Other Identifiers

PT0030901

Identifier Type: -

Identifier Source: org_study_id