Randomized, Crossover Safety and Pharmacokinetics Study of PT010

Study Overview
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Brief Summary
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Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days.

Detailed Description
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This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period, ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy adult subjects of Japanese descent. Safety and PK will be assessed following a single dose and during twice-daily (BID) chronic dosing for 7 days.

Official Title
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A Phase I, Randomized, Double Blind, Placebo-Controlled, Two Period, Ascending Dose, Crossover Study to Assess the Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese Descent Following a Single Dose and After Chronic Dosing for 7 Days

Conditions
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COPD

Intervention / Treatment
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* Drug: PT010 Dose 1
* Drug: PT010 Dose 2
* Drug: Placebo MDI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed Consent Form (ICF) prior to any study related procedures Male and female subjects first generation Japanese subjects 18 to 55 years, inclusive Body weight ≥50 kg (110 lbs) at the Screening Visit and body mass index between 18.5 and 32 kg/m2, 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT010 Dose 1<br>PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. | Drug: PT010 Dose 1<br>* PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.<br>|
| Experimental: PT010 Dose 2<br>PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations. | Drug: PT010 Dose 2<br>* PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.<br>|
| Placebo Comparator: Placebo MDI<br>Placebo MDI. Administered as 2 inhalations | Drug: Placebo MDI<br>* Placebo MDI. Administered as 2 inhalations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic profile of PT010 | The pharmacokinetic profile of PT010 will be assessed at the first day (Day 1) and last dose (Day 8) in each Treatment Period based on: maximum plasma concentration (Cmax) area under the plasma concentration-time curve from 0 to 12 hours (AUC0 12) area under the plasma concentration-time curve from 0 to the time of the last measureable plasma concentration (AUC0-t) area under the plasma concentration-time curve from 0 extrapolated to infinity (AUC0-∞) (only calculated for Day 1) time to maximum plasma concentration (tmax) apparent terminal elimination half-life (t½) apparent total body clearance (CL/F) apparent volume of distribution (Vd/F) terminal elimination rate constant (λz) accumulation ratio for Cmax (RAC [Cmax]) accumulation ratio for AUC0 12 (RAC [AUC0 12]) Other PK parameters may be calculated, as appropriate. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall safety of PT010 | The safety associated with the use of PT010 will be assessed from physical examination findings, adverse event (AE) reporting, vital signs, clinical laboratory values, and findings from 12 lead electrocardiograms (ECGs). | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteers