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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
NCT02812394 |
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Date of registration:
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22/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
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Scientific 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 |
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Date of first enrolment:
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June 2016 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02812394 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Charles Oh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Acorda Therapeutics |
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Key inclusion & exclusion 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
Age minimum:
25 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: CVT-301 (Dose Level 2)
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Drug: CVT-301 (Dose Level 1)
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Drug: Sinemet®
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Primary Outcome(s)
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Maximum observed plasma drug concentration (Cmax)
[Time Frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.]
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Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
[Time Frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.]
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Secondary Outcome(s)
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Number of subjects with Adverse Events (AEs) including Serious AEs
[Time Frame: up to 9 days]
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Secondary ID(s)
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CVT-301-010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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