A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

Study Overview
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Brief Summary
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This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

Detailed Description
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The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.

Official Title
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A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: CVT-301 (Dose Level 1)
* Drug: CVT-301 (Dose Level 2)
* Drug: Sinemet®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation; FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender; Body Mass Index (BMI) between 18 - 30 kg/m2 Exclusion Criteria: No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit; Negative drug and alcohol testing; Negative pregnancy test for female subjects

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CVT-301<br>CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler. CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler. Sinemet® (carbidopa/levodopa) | Drug: CVT-301 (Dose Level 1)<br>* All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.<br>Drug: CVT-301 (Dose Level 2)<br>* All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.<br>Drug: Sinemet®<br>* All subjects will receive carbidopa/levodopa tablets administered every 8 hours.<br>* Other names: carbidopa/levodopa;|

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 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose. | 
| Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h) |  | within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events (AEs) including Serious AEs |  | up to 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Episodic motor fluctuations (OFF periods)