Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-02-19 @ 11:55 AM
Study NCT ID:
NCT02953132
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2016-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-16', 'studyFirstSubmitDate': '2016-10-31', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability as measured by incidence and severity of adverse events', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety and Tolerability as measured by vital signs', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety and Tolerability as measured by ECG', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety and Tolerability as measured by clinical laboratory assessments', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety and Tolerability as measured by Hormone assessments', 'timeFrame': 'Up to Day 10'}, {'measure': 'Safety and Tolerability as measured by physical examination', 'timeFrame': 'Up to Day 14'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Measured time of maximum observed plasma concentration (tmax) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Apparent terminal elimination half-life (t1/2) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'AUC from time zero to 24 hours post-dose (AUC0-24) of MT-4129', 'timeFrame': 'Up to Day 8'}, {'measure': 'AUC from time zero to 48 hours post-dose (AUC0-48) of MT-4129', 'timeFrame': 'Up to Day 9'}, {'measure': 'AUC from time zero to 72 hours post-dose (AUC0-72) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'AUC from time zero to infinity (AUC0-∞) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'AUC from time zero to the last measurable concentration (AUC0-last) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'AUC over the dosing interval (AUC0-t) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Terminal elimination rate constant (Kel) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Mean residence time (MRT) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Apparent volume of distribution during terminal phase after oral administration (Vz/F) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Apparent volume of distribution at steady state (Vss/F) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Apparent oral clearance (CL/F) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Urinary excreted amount of test compound (Ae) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Urinary excreted amount of test compound expressed as a percentage of the dose administered (Ae%) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Renal clearance (CLR) of MT-4129', 'timeFrame': 'Up to Day 10'}, {'measure': 'Plasma aldosterone', 'timeFrame': 'Up to Day 10'}, {'measure': 'Serum cortisol', 'timeFrame': 'Up to Day 10'}, {'measure': 'Plasma steroid hormones', 'timeFrame': 'Up to Day 10'}, {'measure': 'Urinary aldosterone', 'timeFrame': 'Up to Day 10'}, {'measure': 'Urinary cortisol', 'timeFrame': 'Up to Day 10'}, {'measure': 'Urinary sodium', 'timeFrame': 'Up to Day 10'}, {'measure': 'Urine potassium', 'timeFrame': 'Up to Day 10'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and tolerability of ascending single and multiple oral doses of MT-4129 in healthy 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 for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2\n\nExclusion Criteria:\n\n* Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks\n* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, neurological, 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': 'NCT02953132', 'briefTitle': 'A Clinical Study to See How the Study Drug MT-4129 is Taken up by the Body in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Randomised, Double-Blind, Placebo-Controlled, First-Time-in-Human Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-4129 in Healthy Subjects; Including the Effect of Gender and Age on the Pharmacokinetics of a Single Dose of MT-4129 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MT-4129-E01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single ascending dose, MT-4129 or Placebo', 'interventionNames': ['Drug: MT-4129', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple ascending dose, MT-4129 or Placebo', 'interventionNames': ['Drug: MT-4129', 'Drug: Placebo']}], 'interventions': [{'name': 'MT-4129', 'type': 'DRUG', 'armGroupLabels': ['Multiple ascending dose, MT-4129 or Placebo', 'Single ascending dose, MT-4129 or Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Multiple ascending dose, MT-4129 or Placebo', 'Single ascending dose, MT-4129 or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'City Name', 'country': 'Netherlands', 'facility': 'Pharmaceutical Research Associates (PRA) Health Sciences'}], 'overallOfficials': [{'name': 'General Manager', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}