A Phase I, Randomized, Double-Blind, Single-Dose, Three-Period, Three-Treatment, Cross-Over Study Evaluating the Pharmacokinetics and Safety of a Single Dose of PT010, a Single Dose of PT009, and a Single Dose of Open-Label Symbicort® Turbohaler® in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- PT009
- Conditions
- COPD
- Sponsor
- Pearl Therapeutics, Inc.
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Overall Safety of PT010, PT009 and Symbicort Turbohaler
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Intervention: PT009
PT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Intervention: Symbicort Turbohaler
PT009
PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Intervention: PT010
PT009
PT009; Budesonide and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
Intervention: Symbicort Turbohaler
Symbicort Turbohaler
Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
Intervention: PT010
Symbicort Turbohaler
Symbicort Turbohaler; Budesonide and Formoterol Fumarate Inhalation Powder taken as 2 inhalations
Intervention: PT009
Outcomes
Primary Outcomes
Overall Safety of PT010, PT009 and Symbicort Turbohaler
Time Frame: 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 Outcomes
- ◦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)
- ◦Termination elimination rate constant (λz) of PT010, PT009, and Symbicort Turbohaler(12 Hour post dose)