Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-28 @ 7:09 PM
Study NCT ID:
NCT02812394
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2016-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009265', 'term': 'carbidopa, levodopa drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2016-06-22', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2016-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma drug concentration (Cmax)', 'timeFrame': 'within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.'}, {'measure': 'Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)', 'timeFrame': 'within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with Adverse Events (AEs) including Serious AEs', 'timeFrame': 'up to 9 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Episodic motor fluctuations (OFF periods)'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;\n* FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;\n* Body Mass Index (BMI) between 18 - 30 kg/m2\n\nExclusion Criteria:\n\n* No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;\n* Negative drug and alcohol testing;\n* Negative pregnancy test for female subjects'}, 'identificationModule': {'nctId': 'NCT02812394', 'briefTitle': 'A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acorda Therapeutics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CVT-301-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CVT-301', 'description': '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.\n\nCVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler.\n\nSinemet® (carbidopa/levodopa)', 'interventionNames': ['Drug: CVT-301 (Dose Level 1)', 'Drug: CVT-301 (Dose Level 2)', 'Drug: Sinemet®']}], 'interventions': [{'name': 'CVT-301 (Dose Level 1)', 'type': 'DRUG', 'description': 'All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.', 'armGroupLabels': ['CVT-301']}, {'name': 'CVT-301 (Dose Level 2)', 'type': 'DRUG', 'description': 'All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.', 'armGroupLabels': ['CVT-301']}, {'name': 'Sinemet®', 'type': 'DRUG', 'otherNames': ['carbidopa/levodopa'], 'description': 'All subjects will receive carbidopa/levodopa tablets administered every 8 hours.', 'armGroupLabels': ['CVT-301']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75247', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Site #001', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Charles Oh, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Acorda Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acorda Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}