Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
Study NCT ID:
NCT04465266
Status:
COMPLETED
Last Update Posted:
2022-02-01
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 PK Study of Tolperisone in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014049', 'term': 'Tolperisone'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'sequence randomized'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'taken over 4 days per dose', 'description': 'Maximum plasma concentration of tolperisone'}, {'measure': 'Tmax', 'timeFrame': 'taken over 4 days per dose', 'description': 'Time of maximum plasma concentration of tolperisone'}, {'measure': 'AUC', 'timeFrame': 'taken over 4 days per dose', 'description': 'Area under the curve of tolperisone plasma concentrations'}, {'measure': 'T1/2', 'timeFrame': 'taken over 4 days per dose', 'description': 'Half life of tolperisone'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects', 'detailedDescription': 'This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally Healthy Subjects\n* BMI between 18.5 and 32.5 kg/m2\n\nExclusion Criteria:\n\n\\- pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04465266', 'briefTitle': 'A Phase 1 PK Study of Tolperisone in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurana Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CLN-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '50 mg Tolperisone', 'description': '50 mg tablets (2 days SD, 2 days TID)', 'interventionNames': ['Drug: Tolperisone']}, {'type': 'EXPERIMENTAL', 'label': '100 mg of Tolperisone', 'description': '100 mg tablets (2 days SD, 2 days TID)', 'interventionNames': ['Drug: Tolperisone']}, {'type': 'EXPERIMENTAL', 'label': '200 mg Tolperisone', 'description': '200 mg tablets (2 days SD, 2 days TID)', 'interventionNames': ['Drug: Tolperisone']}], 'interventions': [{'name': 'Tolperisone', 'type': 'DRUG', 'description': 'tablets', 'armGroupLabels': ['100 mg of Tolperisone', '200 mg Tolperisone', '50 mg Tolperisone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials Early Phase Services, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurana Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}