Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT02429102
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2015-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2015-04-16', 'studyFirstSubmitQcDate': '2015-04-28', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability as measured by vital signs', 'timeFrame': 'up to Day14'}, {'measure': 'Safety and Tolerability as measured by ECG', 'timeFrame': 'up to Day14'}, {'measure': 'Safety and Tolerability as measured by continuous lead II ECG monitoring', 'timeFrame': 'up to Day14'}, {'measure': 'Safety and Tolerability as measured by laboratory safety assessments', 'timeFrame': 'up to Day14'}, {'measure': 'Safety and Tolerability as measured by physical examination', 'timeFrame': 'up to Day14'}, {'measure': 'Safety and Tolerability as measured by number of participants with adverse events', 'timeFrame': 'up to Day14'}], 'secondaryOutcomes': [{'measure': 'PK profile (Cmax, tmax, t½, AUC)', 'timeFrame': '240 hours post dose', 'description': 'Cmax, tmax, t½, AUC'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1', 'Healthy subjects', 'Pharmacokinetics of MT-8554'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy and free from clinically significant illness or disease\n* Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65\n* A body weight of ≥60 kg male and ≥50 kg female\n\nExclusion Criteria:\n\n* Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks.\n* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder.\n* Clinically relevant abnormal medical history, physical findings or laboratory values'}, 'identificationModule': {'nctId': 'NCT02429102', 'briefTitle': 'A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'orgStudyIdInfo': {'id': 'MT-8554-E01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single ascending dose, MT-8554 or Placebo', 'interventionNames': ['Drug: MT-8554', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple ascending dose, MT-8554 or Placebo', 'interventionNames': ['Drug: MT-8554', 'Drug: Placebo']}], 'interventions': [{'name': 'MT-8554', 'type': 'DRUG', 'armGroupLabels': ['Multiple ascending dose, MT-8554 or Placebo', 'Single ascending dose, MT-8554 or Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Multiple ascending dose, MT-8554 or Placebo', 'Single ascending dose, MT-8554 or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'City Name', 'country': 'United Kingdom', 'facility': 'Investigational center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}