Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-05 @ 11:51 AM
Study NCT ID:
NCT02803268
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2016-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2016-06-14', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability as measured by vital signs', 'timeFrame': 'Up to Day 21'}, {'measure': 'Safety and Tolerability as measured by number of participants with adverse events', 'timeFrame': 'Up to Day 21'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration of MT-8554 after dosing', 'timeFrame': 'Up to Day 15'}, {'measure': 'Change from baseline in core body temperature', 'timeFrame': 'Up to Day 14'}, {'measure': 'Frequency of Vasomotor Symptoms', 'timeFrame': 'Up to Day 15'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Vasomotor Symptoms']}, 'descriptionModule': {'briefSummary': 'A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must meet one of the following criteria:Woman aged ≥18 years with histologically proven non-metastatic breast cancer (Stages I, II or III) and without evidence of disease / Woman aged ≥40 years who are post-menopausal / Woman aged ≥40 years who are peri-menopausal\n* Subjects who have ≥7 Vasomotor Symptoms per day on average\n* A body weight of ≥45 kg\n\nExclusion Criteria:\n\n* Participation in more than three clinical studies involving administration of an unlicensed Investigational Medicinal Product 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': 'NCT02803268', 'briefTitle': 'A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of MT-8554 in Female Subjects Experiencing Vasomotor Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'orgStudyIdInfo': {'id': 'MT-8554-E04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MT-8554 low dose', 'description': 'Patients who meet eligibility criteria will be administered once daily either low dose of MT-8554 or a matching Placebo from Day 1 to 14.', 'interventionNames': ['Drug: MT-8554 low dose', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MT-8554 middle dose', 'description': 'Patients who meet eligibility criteria will be administered once daily either middle dose of MT-8554 or a matching Placebo from Day 1 to 14.', 'interventionNames': ['Drug: MT-8554 middle dose', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'MT-8554 high dose', 'description': 'Patients who meet eligibility criteria will be administered once daily either high dose of MT-8554 or a matching Placebo from Day 1 to 14.', 'interventionNames': ['Drug: MT-8554 high dose', 'Drug: Placebo']}], 'interventions': [{'name': 'MT-8554 low dose', 'type': 'DRUG', 'armGroupLabels': ['MT-8554 low dose']}, {'name': 'MT-8554 middle dose', 'type': 'DRUG', 'armGroupLabels': ['MT-8554 middle dose']}, {'name': 'MT-8554 high dose', 'type': 'DRUG', 'armGroupLabels': ['MT-8554 high dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['MT-8554 high dose', 'MT-8554 low dose', 'MT-8554 middle dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'City Name', 'country': 'Germany', 'facility': 'Investigational center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}