COPD
Conditions
Keywords
Healthy volunteers
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.
Interventions
DRUGPT010
PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
DRUGPT009
PT009 administered as 2 inhalations
Symbicort Turbohaler taken as 2 inhalations
Sponsors
Pearl Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| ◦Apparent volume of distribution (Vd/F) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
| ◦Maximum plasma concentration (Cmax) 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 to the time of the last measureable plasma concentration (AUC0 t) 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 |
| ◦Time to maximum plasma concentration (tmax) 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 extrapolated to infinity (AUC0-∞) of PT010, PT009, and Symbicort Turbohaler | 12 Hour post dose |
Countries
United States
Outcome results
None listed