Pharmacokinetics and Safety Study of PT010 in Healthy Subjects
- Registration Number
- NCT02189304
- Lead Sponsor
- Pearl Therapeutics, Inc.
- Brief Summary
This is a single-center, Phase I, healthy adult subject study with a randomized, double blind, three period, three-treatment, cross-over design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
Inclusion Criteria
- Informed Consent Form (ICF) prior to any study related procedures
- Male and female subjects 18 to 55 years, inclusive
- Good general health
- Medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
- Clinical labs within normal ranges or determined to be not clinically significant by the Investigator
Exclusion Criteria
- Pregnancy, nursing female subjects, or subjects trying to conceive
- Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- History of ECG abnormalities
- Cancer not in complete remission for at least 5 years
- Clinically significant, symptomatic prostatic hypertrophy
- Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
- Clinically significant bladder neck obstruction or urinary retention
- Inadequately treated glaucoma
- History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study
- Subjects with pre-existing anemia and/or iron deficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PT010 Symbicort Turbohaler PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations PT009 Symbicort Turbohaler PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations PT010 PT009 PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations PT009 PT010 PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations Symbicort Turbohaler PT010 Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations Symbicort Turbohaler PT009 Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
- Primary Outcome Measures
Name Time Method Overall Safety of PT010, PT009 and Symbicort Turbohaler 12 hours post dose The safety of PT010 and PT009 and Symbicort Turbohaler will be assessed based on physical examination, adverse events, vital signs, clinical laboratory values, and electrocardiogram
- Secondary Outcome Measures
Name Time Method ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler 12 Hour post dose ◦Maximum plasma concentration (Cmax) of PT010, PT009 and Symbicort Turbohaler 12 Hour post dose ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler 12 Hour post dose ◦Area under the curve from 0 to the time of the last measureable plasma concentration (AUC0 t) of PT010, PT009 and Symbicort Turbohaler 12 Hour post dose ◦Apparent terminal elimination half life (t½) of PT010, PT009, and Symbicort Turbohaler 12 Hour post dose ◦Apparent total body clearance (CL/F) of PT010, PT009, and Symbicort Turbohaler 12 Hour post dose ◦Area under the curve from 0 to 12 hours (AUC0 12) of PT010, PT009 and Symbicort Turbohaler 12 Hour post dose ◦Area under the curve from 0 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler 12 Hour post dose ◦Time to maximum plasma concentration (tmax) of PT010, PT009, and Symbicort Turbohaler 12 Hour post dose
Trial Locations
- Locations (1)
SNBL Clinical Pharmacology Center
🇺🇸Baltimore, Maryland, United States