A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Study Overview
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Brief Summary
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Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010

Detailed Description
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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

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Regimen A
* Drug: Regimen B
* Drug: Regimen C
* Drug: Regimen D


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Period 1<br>Test Formulation (Regimen B or D) or Reference Formulation (Regimen A or C) | Drug: Regimen A<br>* 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure<br>Drug: Regimen B<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure<br>Drug: Regimen C<br>* 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure<br>Drug: Regimen D<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure<br>|
| Experimental: Treatment Period 2<br>Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) | Drug: Regimen A<br>* 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure<br>Drug: Regimen B<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure<br>Drug: Regimen C<br>* 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure<br>Drug: Regimen D<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure<br>|
| Experimental: Treatment Period 3<br>Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) | Drug: Regimen A<br>* 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure<br>Drug: Regimen B<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure<br>Drug: Regimen C<br>* 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure<br>Drug: Regimen D<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure<br>|
| Experimental: Treatment Period 4<br>Test Formulation (Regimen (B or D) or Reference Formulation (Regimen A or C) | Drug: Regimen A<br>* 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure<br>Drug: Regimen B<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure<br>Drug: Regimen C<br>* 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure<br>Drug: Regimen D<br>* 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax)-Budesonide | Maximum plasma concentration (Cmax) per Regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose | 
| Maximum Plasma Concentration (Cmax)-Glycopyrronium | Maximum plasma concentration (Cmax) per Regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose | 
| Maximum Plasma Concentration (Cmax)-Formoterol | Maximum plasma concentration (Cmax) per Regimen | 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 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Budesonide | Each treatment period is equal to assigned regimen | 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 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Glycopyrronium | Each treatment period is equal to assigned regimen | 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 the Time of the Last Measurable Plasma Concentration (AUC0-tlast)-Formoterol | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Maximum Plasma Concentration (Tmax)-Budesonide | Each treatment period is equal to assigned regimen | Pre-dose and 2, 6, 20, 40 min, 1, 2, 4, 8, 12 and 24 h post-dose | 
| Time to Maximum Plasma Concentration (Tmax)-Glycopyrronium | Each treatment period is equal to assigned regimen | 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 | Each treatment period is equal to assigned regimen | 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-∞);-Budesonide | Each treatment period is equal to assigned regimen | 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 | Each treatment period is equal to assigned regimen | 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 | Each treatment period is equal to assigned regimen | 24 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD