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

Pearl Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PT001 + PT005; Drug: PT003; Drug: PT005; Drug: PT001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00893971

PT0030901

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 4 patient groups

1

Experimental group

Description:

Inhaled PT001 18 μg

Treatment:

Drug: PT001

2

Experimental group

Description:

Inhaled PT005 2.4 μg

Treatment:

Drug: PT005

3

Experimental group

Description:

Inhaled PT003 (PT001 18 μg / 2.4 μg PT005)

Treatment:

Drug: PT003

4

Experimental group

Description:

PT001 18 μg + PT005 2.4 μg

Treatment:

Drug: PT001 + PT005