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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00893971




Registration number
NCT00893971
Ethics application status
Date submitted
5/05/2009
Date registered
5/05/2009
Date last updated
16/03/2017

Titles & IDs
Public title
Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
PT0030901
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PT001
Treatment: Drugs - PT005
Treatment: Drugs - PT003
Treatment: Drugs - PT001 + PT005

Experimental: 1 - Inhaled PT001 18 µg

Experimental: 2 - Inhaled PT005 2.4 µg

Experimental: 3 - Inhaled PT003 (PT001 18 µg / 2.4 µg PT005)

Experimental: 4 - PT001 18 µg + PT005 2.4 µg


Treatment: Drugs: PT001
Inhaled PT001, single dose

Treatment: Drugs: PT005
Inhaled PT005, single dose

Treatment: Drugs: PT003
Inhaled PT003, single dose

Treatment: Drugs: PT001 + PT005
Inhaled PT001 + PT005, single dose

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Symptoms of Dry Mouth - Number of participants reporting dry mouth at 12 hours post-dose
Timepoint [1] 0 0
12 hours
Primary outcome [2] 0 0
Symptoms of Tremor - Number of participants reporting tremor at 12 hours post-dose
Timepoint [2] 0 0
12 hours
Primary outcome [3] 0 0
Blood Chemistry Change From Baseline - Series of 11 blood chemistries assessed throughout the study
Timepoint [3] 0 0
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Primary outcome [4] 0 0
Hematology Change From Baseline - Hematology assessments taken throughout the study Hematocrit
Timepoint [4] 0 0
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Primary outcome [5] 0 0
Hematology Change From Baseline - Hematology assessments taken throughout the study
Timepoint [5] 0 0
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Primary outcome [6] 0 0
Hematology Change From Baseline - Hematology assessments taken throughout the study Hemoglobin
Timepoint [6] 0 0
24 hours post dose for sentinel subjects, 12 hours post dose for subsequent subjects
Primary outcome [7] 0 0
Heart Rate Change From Baseline - Change from baseline for heart rate 12-hours post-dose Heart rate (bpm)
Timepoint [7] 0 0
12 hours
Primary outcome [8] 0 0
Vital Sign Change Baseline; Blood Pressure - Vital sign change baseline; blood pressure
Timepoint [8] 0 0
12 hours
Primary outcome [9] 0 0
Vital Sign Change From Baseline, SpO2 - Vital Sign Change from baseline 12-hours post-dose SpO2 (%)
Timepoint [9] 0 0
12 hours
Primary outcome [10] 0 0
ECG Change From Baseline - Change from baseline for ECG parameters 12-hours post-dose Ventricular rate (bpm)
Timepoint [10] 0 0
12 hours
Primary outcome [11] 0 0
ECG Change From Baseline - Change from baseline for ECG parameters 12-hours post-dose
Timepoint [11] 0 0
12 hours
Primary outcome [12] 0 0
Spirometry Change From Baseline - Change from baseline for spirometery measures 12-hours post-dose
Timepoint [12] 0 0
12 hours
Primary outcome [13] 0 0
Spirometry Change From Baseline - Change from baseline for spirometery measures 12-hours post-dose (FEV1 % predicted)
Timepoint [13] 0 0
12 hours
Primary outcome [14] 0 0
Spirometry Change From Baseline - Change from baseline for spirometery measures 12-hours post-dose FEV/FVC (%)
Timepoint [14] 0 0
12 hours
Primary outcome [15] 0 0
Spirometry Change From Baseline - Change from baseline for spirometery measures 12-hours post-dose PEFR (L/min)
Timepoint [15] 0 0
12 hours
Primary outcome [16] 0 0
Serum Potassium Change From Baseline
Timepoint [16] 0 0
12 hours
Secondary outcome [1] 0 0
Plasma Glycopyrrolate PK Parameters - Various pharmacokinetic parameters for plasma glycopyrrolate
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Plasma Glycopyrrolate PK Parameters AUC0-inf (h*pg/mL) - Various pharmacokinetic parameters for plasma glycopyrrolate
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Plasma Glycopyrrolate PK Parameters (Tmax) - Various pharmacokinetic parameters for plasma glycopyrrolate
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Plasma Glycopyrrolate PK Parameters (t1/2) - Various pharmacokinetic parameters for plasma glycopyrrolate
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Plasma Glycopyrrolate PK Parameters Cmax (pg/mL) - Various pharmacokinetic parameters for plasma glycopyrrolate
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Plasma Glycopyrrolate PK Parameters (ke) - Various pharmacokinetic parameters for plasma glycopyrrolate
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Plasma Formoterol PK Parameters - Various pharmacokinetic parameters for plasma formoterol
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Plasma Formoterol PK Parameters AUC0-inf (h*pg/mL) - Various pharmacokinetic parameters for plasma formoterol
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Plasma Formoterol PK Parameters (Tmax) - Various pharmacokinetic parameters for plasma formoterol
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
Plasma Formoterol PK Parameters (t1/2) - Various pharmacokinetic parameters for plasma formoterol
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Plasma Formoterol PK Parameters (Cmax) - Pharmacokinetic parameters for plasma formoterol Cmax
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Plasma Formoterol PK Parameters (ke) - Pharmacokinetic parameters for plasma formoterol ke
Timepoint [12] 0 0
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

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Dr Joanne Marjason - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pearl Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00893971
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colin Reisner, M.D.
Address 0 0
Pearl Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications