Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-22 @ 9:54 AM
Study NCT ID:
NCT02770404
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2016-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627038', 'term': 'nafithromycin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-31', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve', 'timeFrame': '72 hours from dosing'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': '72 hours from dosing'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': '72 hours from dosing'}], 'secondaryOutcomes': [{'measure': 'clinical laboratory- Number of subjects with deranged heamatology parameters test results', 'timeFrame': '14 days'}, {'measure': '12-lead safety ECG results', 'timeFrame': '14 days'}, {'measure': 'Number of subjects reported with any local tolerability at the injection site assessments', 'timeFrame': '14 days'}, {'measure': 'Number of subjects with any abonormal physical examination findings', 'timeFrame': '14 days'}, {'measure': 'Total number of reported AEs', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, single-center, placebo-controlled, sequential-cohort study in at least 60 healthy adult male and female subjects. Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments. Subjects in Cohort 6 will be randomly assigned in a 1:1 allocation to receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period. Subjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin or matching placebo on Day 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subject between 18 and 55 years of age, both inclusive,\n* creatinine clearance ≥80 mL/minute (Cockcroft-Gault method).\n\nExclusion Criteria:\n\n1. Clinically relevant pathology or any other systemic disorder/major surgeries that in the opinion of the investigator would confound the subject's participation and follow-up in the clinical study.\n2. Drug or food allergy."}, 'identificationModule': {'nctId': 'NCT02770404', 'briefTitle': 'A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wockhardt'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'W-4873-102 SAD study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nafithromycin', 'description': 'Subjects in Cohorts 1 through 5 receive active treatments. Subjects in Cohort 6 will receive an IV dose of nafithromycin and a single oral dose of nafithromycin in each crossover period.\n\nSubjects in each of Cohorts 1, 2, and 3 will receive a single dose of 100, 200, or 400 mg, respectively, of nafithromycin on Day 1', 'interventionNames': ['Drug: Nafithromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects in Cohorts 1 through 5 will be randomly assigned in an 8:2 allocation to receive active or placebo treatments.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Nafithromycin', 'type': 'DRUG', 'description': '100, 200, or 400 mg of nafithromycin', 'armGroupLabels': ['Nafithromycin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Matching IV placebo'], 'description': 'IV matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53095', 'city': 'West Bend', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Phase 1 unit : Spaulding Clinical Research, LLC', 'geoPoint': {'lat': 43.42528, 'lon': -88.18343}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wockhardt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}