A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Regimen A
Regimen B
Regimen C
Regimen D
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
Key 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
Key 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
- Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration
- Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
Sites / Locations
- Pearl Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment Period 1
Treatment Period 2
Treatment Period 3
Treatment Period 4
Arm Description
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Outcomes
Primary Outcome Measures
Maximum Plasma Concentration (Cmax)-Budesonide
Maximum plasma concentration (Cmax) per Regimen
Maximum Plasma Concentration (Cmax)-Glycopyrronium
Maximum plasma concentration (Cmax) per Regimen
Maximum Plasma Concentration (Cmax)-Formoterol
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
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)-Glycopyrronium
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
Each treatment period is equal to assigned regimen
Secondary Outcome Measures
Time to Maximum Plasma Concentration (Tmax)-Budesonide
Each treatment period is equal to assigned regimen
Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium
Each treatment period is equal to assigned regimen
Time to Maximum Plasma Concentration (Tmax)-Formoterol
Each treatment period is equal to assigned regimen
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide
Each treatment period is equal to assigned regimen
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium
Each treatment period is equal to assigned regimen
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol
Each treatment period is equal to assigned regimen
Full Information
NCT ID
NCT03311373
First Posted
October 11, 2017
Last Updated
June 8, 2020
Sponsor
Pearl Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03311373
Brief Title
A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
December 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pearl Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Period 1
Arm Type
Experimental
Arm Description
Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C)
Arm Title
Treatment Period 2
Arm Type
Experimental
Arm Description
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Arm Title
Treatment Period 3
Arm Type
Experimental
Arm Description
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Arm Title
Treatment Period 4
Arm Type
Experimental
Arm Description
Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C)
Intervention Type
Drug
Intervention Name(s)
Regimen A
Intervention Description
2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure
Intervention Type
Drug
Intervention Name(s)
Regimen B
Intervention Description
2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure
Intervention Type
Drug
Intervention Name(s)
Regimen C
Intervention Description
2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure
Intervention Type
Drug
Intervention Name(s)
Regimen D
Intervention Description
2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure
Primary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax)-Budesonide
Description
Maximum plasma concentration (Cmax) per Regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Maximum Plasma Concentration (Cmax)-Glycopyrronium
Description
Maximum plasma concentration (Cmax) per Regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Maximum Plasma Concentration (Cmax)-Formoterol
Description
Maximum plasma concentration (Cmax) per Regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Area Under the Plasma Concentration-time Curve From 0 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Secondary Outcome Measure Information:
Title
Time to Maximum Plasma Concentration (Tmax)-Budesonide
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Time to Maximum Plasma Concentration (Tmax)-Formoterol
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Budesonide
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Glycopyrronium
Description
Each treatment period is equal to assigned regimen
Time Frame
Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose
Title
Area Under the Plasma Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-∞);-Formoterol
Description
Each treatment period is equal to assigned regimen
Time Frame
24 hrs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key 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
Key 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
Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of drug administration or who have been vaccinated with an attenuated live virus within 4 weeks of drug administration
Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (eg, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul M. Dorinsky, MD
Organizational Affiliation
Pearl Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Pearl Investigative Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
32253054
Citation
Dorinsky P, DePetrillo P, DeAngelis K, Trivedi R, Darken P, Gillen M. Relative Bioavailability of Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Administered With and Without a Spacer: Results of a Phase I, Randomized, Crossover Trial in Healthy Adults. Clin Ther. 2020 Apr;42(4):634-648. doi: 10.1016/j.clinthera.2020.02.012. Epub 2020 Apr 3.
Results Reference
derived
Links:
URL
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URL
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A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
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