Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-25 @ 1:20 PM
Study NCT ID:
NCT03979859
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2019-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2013-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-06', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessing incidence of treatment emergent AEs', 'timeFrame': 'Day 24', 'description': 'By abnormal clinical laboratory (including liver function tests) findings'}, {'measure': 'Assessing incidence of treatment emergent AEs', 'timeFrame': 'Day 24', 'description': 'By variation in physical examination'}, {'measure': 'Assessing incidence of treatment emergent AEs', 'timeFrame': 'Day 24', 'description': 'By abnormal findings in eye movement test and visual acuity test'}, {'measure': 'Assessing incidence of treatment emergent AEs', 'timeFrame': 'Day 24', 'description': 'By abnormal vital signs'}, {'measure': 'Assessing incidence of treatment emergent AEs', 'timeFrame': 'Day 24', 'description': 'variations in 12-lead electrocardiogram'}, {'measure': 'Measure the pharmacokinetic parameter: Area Under Curve (AUC)', 'timeFrame': 'Day 10', 'description': 'plasma PK parameters area under curve (AUC)'}, {'measure': 'Measure the pharmacokinetic parameter-plasma PK concentration', 'timeFrame': 'Day 10', 'description': 'Plasma concentration -Cmax'}, {'measure': 'Measure the pharmacokinetic parameter- Time', 'timeFrame': 'Day 10', 'description': 'Plasma PK parameter- Tmax'}, {'measure': 'Measure the pharmacokinetic parameter- Time', 'timeFrame': 'Day 10', 'description': 'Plasma PK parameter- T1/2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, double-blind, single center, placebo-controlled, sequential cohort study in a maximum of 3 cohorts of 10 healthy male and/or female subjects each. Subjects in Cohorts 1, 2 and 3 will receive ascending multiple oral doses of WCK 4873 or matching placebo once daily on Days 1 to 7. Dosing will be conducted under fed conditions on each dosing day. The dose levels to be administered will be based on the safety, tolerability and PK results of the single dose and food effect study (W 4873 01 study; PRA-code WOE384EC-123841).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI : 18.0-30.0 kg/m2 (Body Mass Index \\[BMI\\] \\[kg/m2\\] = Body weight \\[kg\\] Height2 \\[m2\\])\n* Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power-drinks"), grapefruit (juice) from 48 h prior to entry in the clinical research center until discharge\n* Medical history without major pathology as judged by the Principal Investigator\n* Resting supine blood pressure 90-139 (systolic) / 40-89 (diastolic) mmHg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator\n* Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the Principal -Investigator. QTcF should be \\<450 ms\n\nExclusion Criteria:\n\n* Previous participation in the current study\n* Evidence of clinically relevant pathology\n* Mental handicap\n* History of Myasthenia Gravis\n* History of hepatitis and/or jaundice associated with the use of any antibiotic\n* Congenital prolongation of the QTc interval, ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia\n* History of relevant drug and/or food allergies\n* Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center\n* Smoking within 60 days prior to drug administration and through the follow-up visit\n* History of alcohol abuse or drug addiction (including soft drugs like cannabis products)'}, 'identificationModule': {'nctId': 'NCT03979859', 'briefTitle': 'Evaluate The Safety, Tolerability and Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wockhardt'}, 'officialTitle': 'Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Multiple Ascending Oral Doses Of WCK 4873 In Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'W 4873 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WCK 4873', 'description': '200 and 400 mg tablets Dosage form : Oral tablets Doses : To be determined based on the safety, tolerability and PK results of the single dose and food effect study', 'interventionNames': ['Drug: WCK 4873']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Visually matching placebo', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'WCK 4873', 'type': 'DRUG', 'armGroupLabels': ['WCK 4873']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wockhardt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}