A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal
Overview
- Phase
- Phase 1
- Intervention
- Regimen A
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Pearl Therapeutics, Inc.
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Maximum Plasma Concentration (Cmax)-Budesonide
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Detailed Description
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010 Administered With and Without a Spacer, and With and Without Oral Charcoal
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening procedures are performed
- •Male and female subjects 18 to 40 years of age, inclusive
- •Be in good general health as determined by a thorough medical history and physical examination, ECG, vital signs, and clinical laboratory evaluation
- •Non-childbearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal, or surgically sterile
- •Male subjects who are sexually active must agree to use a double-barrier method of contraception (condom with spermicide) from the first dose of randomized study drug until 2 weeks after their last dose, and must not donate sperm during their study participation period
- •Screening laboratory tests must be within normal range or determined to not be clinically significant by the Investigator.
- •Demonstrate correct MDI administration technique
Exclusion Criteria
- •For female subjects, a positive serum human chorionic gonadotropin (hCG) test at screening or a positive urine hCG at admission for any of the 4 Treatment Periods
- •Subjects with clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
- •Subjects who have cancer that has not been in complete remission for at least 5 years
- •Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to screening
- •Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator
- •History of substance-related disorders (with the exception of caffeine-related and nicotine-related disorders) within 1 year of screening
- •History of smoking or the use of nicotine-containing products within 3 months of screening by self-reporting
- •A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening or at the beginning of each Treatment Period
- •Treatment with any prescription or non-prescription drugs including vitamins, herbal, and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study drug use
- •Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the beginning of the screening Period
Arms & Interventions
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen A
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen B
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen C
Treatment Period 1
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen D
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen A
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen B
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen C
Treatment Period 2
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen D
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen A
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen B
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen C
Treatment Period 3
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen D
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen A
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen B
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen C
Treatment Period 4
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention: Regimen D
Outcomes
Primary Outcomes
Maximum Plasma Concentration (Cmax)-Budesonide
Time Frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Maximum Plasma Concentration (Cmax)-Formoterol
Time Frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium
Time Frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
Maximum Plasma Concentration (Cmax)-Glycopyrronium
Time Frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Maximum plasma concentration (Cmax) per Regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide
Time Frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol
Time Frame: Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Each treatment period is equal to assigned regimen
Secondary Outcomes
- Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Time to Maximum Plasma Concentration (Tmax)-Budesonide(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol(24 hrs)
- Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)
- Time to Maximum Plasma Concentration (Tmax)-Formoterol(Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose)