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

Pearl Therapeutics, Inc.16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

PT001DRUG

Inhaled PT001, single dose

PT005DRUG

Inhaled PT005, single dose

PT003DRUG

Inhaled PT003, single dose

PT001 + PT005

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Dr Joanne Marjason

Herston, Queensland, Australia

Outcomes

Primary Outcomes

Symptoms of Dry Mouth

Number of participants reporting dry mouth at 12 hours post-dose

Time frame: 12 hours

Symptoms of Tremor

Number of participants reporting tremor at 12 hours post-dose

Time frame: 12 hours

Blood Chemistry Change From Baseline

Series of 11 blood chemistries assessed throughout the study

Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Hematology Change From Baseline

Hematology assessments taken throughout the study Hematocrit

Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Hematology Change From Baseline

Hematology assessments taken throughout the study

Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Hematology Change From Baseline

Hematology assessments taken throughout the study Hemoglobin

Time frame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects

Heart Rate Change From Baseline

Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)

Time frame: 12 hours

Vital Sign Change Baseline; Blood Pressure

Vital sign change baseline; blood pressure

Time frame: 12 hours

Data from ClinicalTrials.gov

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