Clinical trial NCT00893971: Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Symptoms of Dry Mouth
timeFrame: 12 hours
measure: Symptoms of Tremor
timeFrame: 12 hours
measure: Blood Chemistry Change From Baseline
timeFrame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
measure: Hematology Change From Baseline
timeFrame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
measure: Hematology Change From Baseline
timeFrame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
measure: Hematology Change From Baseline
timeFrame: 24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
measure: Heart Rate Change From Baseline
timeFrame: 12 hours
measure: Vital Sign Change Baseline; Blood Pressure
timeFrame: 12 hours
measure: Vital Sign Change From Baseline, SpO2
timeFrame: 12 hours
measure: ECG Change From Baseline
timeFrame: 12 hours
measure: ECG Change From Baseline
timeFrame: 12 hours
measure: Spirometry Change From Baseline
timeFrame: 12 hours
measure: Spirometry Change From Baseline
timeFrame: 12 hours
measure: Spirometry Change From Baseline
timeFrame: 12 hours
measure: Spirometry Change From Baseline
timeFrame: 12 hours
measure: Serum Potassium Change From Baseline
timeFrame: 12 hours
Secondary outcomes:
measure: Plasma Glycopyrrolate PK Parameters
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Glycopyrrolate PK Parameters (Tmax)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Glycopyrrolate PK Parameters (t1/2)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Glycopyrrolate PK Parameters Cmax (pg/mL)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Glycopyrrolate PK Parameters (ke)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Formoterol PK Parameters
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Formoterol PK Parameters (Tmax)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Formoterol PK Parameters (t1/2)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Formoterol PK Parameters (Cmax)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
measure: Plasma Formoterol PK Parameters (ke)
timeFrame: Concentrations were measured at pre-dose and 2,5,15, and 30 minutes post dose as well as 1,2,4,6,8, and 12 hours post dose
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Dr Joanne Marjason
state: Queensland
Study officials:
affiliation: Pearl Therapeutics
name: Colin Reisner, M.D.
role: STUDY_DIRECTOR
References: