A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

Study Overview
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Brief Summary
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This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.

Official Title
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A Phase 1 Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

Conditions
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Smoking

Intervention / Treatment
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* Drug: CVT-301
* Drug: Carbidopa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) 18 to 32 kg/m2; Forced expiratory volume in one second (FEV1) ≥80% of predicted for race, age, sex, and height; FEV1/FVC (forced vital capacity) ratio ≥70%; Smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease [COPD], chronic bronchitis, or other relevant conditions); Non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result. Exclusion Criteria: Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product; Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit; History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years; Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute; History of syncope within the last 6 months.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults who smoke<br>Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours. Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301. | Drug: CVT-301<br>* Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.<br>Drug: Carbidopa<br>* Administered orally according to the carbidopa dosing schedule.<br>* Other names: Lodosyn ®;|
| Experimental: Adults who don't smoke<br>Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours. Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301. | Drug: CVT-301<br>* Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.<br>Drug: Carbidopa<br>* Administered orally according to the carbidopa dosing schedule.<br>* Other names: Lodosyn ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma drug concentration (Cmax) |  | within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose | 
| Time to maximum observed plasma drug concentration (tmax) |  | within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose | 
| Area under the plasma concentration versus time curve (AUC) |  | within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pulmonary function | Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III) | within 90 min prior to CVT-301 dose and at specified time points up to 24 hours post-dose | 
| Number of subjects with Adverse Events (AEs) including Serious AEs |  | up to 3 days | 

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