Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT01879020
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2013-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597751', 'term': 'TA-8995'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-12', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-12', 'lastUpdatePostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '336 hours post dose'}, {'measure': 'Laboratory tests (haematology, biochemistry and urinalysis)', 'timeFrame': '336 hours post dose'}, {'measure': 'Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)', 'timeFrame': '336 hours post dose'}, {'measure': 'Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)', 'timeFrame': '7 days post the final dose'}, {'measure': "The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)", 'timeFrame': '7 days post the final dose'}], 'secondaryOutcomes': [{'measure': 'Cholesterol ester transfer protein (CETP) activity (%)', 'timeFrame': '7 days post the final dose'}, {'measure': 'CETP concentration (mg/mL)', 'timeFrame': '4 hours after the first and the fibal dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MT-8995', 'Dyslipidemia', 'Cholesteryl ester transfer proteins'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the Investigator.\n* Between 18 - 55 years old.\n* Male of Caucasian ethnic origin.\n* Body mass index (BMI) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. Subjects with a BMI in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm.\n\nExclusion Criteria:\n\n* High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.\n* Abnormal Electrocardiogram (ECG) at Screening or Day -1 including a QTc ≥ 430 ms (The QTc-interval was calculated automatically according to Bazett's formula. In the case of results of ≥ 430 ms, QTc was additionally calculated manually using Fridericia's formula which was used as an exclusion criterion).\n* Family history of long QT syndrome, hypokalaemia or Torsades de Pointes\n* Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness\n* Presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs"}, 'identificationModule': {'nctId': 'NCT01879020', 'briefTitle': 'Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Randomised Double-blind, Placebo-controlled, Ascending-dose, Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Adult Male Subjects', 'orgStudyIdInfo': {'id': 'TA-8995-E02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TA-8995 1 mg', 'interventionNames': ['Drug: TA-8995']}, {'type': 'EXPERIMENTAL', 'label': 'TA-8995 2.5 mg', 'interventionNames': ['Drug: TA-8995']}, {'type': 'EXPERIMENTAL', 'label': 'TA-8995 5 mg', 'interventionNames': ['Drug: TA-8995']}, {'type': 'EXPERIMENTAL', 'label': 'TA-8995 10 mg', 'interventionNames': ['Drug: TA-8995']}, {'type': 'EXPERIMENTAL', 'label': 'TA-8995 25 mg', 'interventionNames': ['Drug: TA-8995']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (TA-8995 1mg)', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (TA-8995 2.5mg)', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (TA-8995 5mg)', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (TA-8995 10mg)', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (TA-8995 25mg)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TA-8995', 'type': 'DRUG', 'description': 'Drug: TA-8995 1mg', 'armGroupLabels': ['TA-8995 1 mg']}, {'name': 'TA-8995', 'type': 'DRUG', 'description': 'Drug: TA-8995 2.5mg', 'armGroupLabels': ['TA-8995 2.5 mg']}, {'name': 'TA-8995', 'type': 'DRUG', 'description': 'Drug: TA-8995 5mg', 'armGroupLabels': ['TA-8995 5 mg']}, {'name': 'TA-8995', 'type': 'DRUG', 'description': 'Drug: TA-8995 10mg', 'armGroupLabels': ['TA-8995 10 mg']}, {'name': 'TA-8995', 'type': 'DRUG', 'description': 'Drug: TA-8995 25mg', 'armGroupLabels': ['TA-8995 25 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (TA-8995 1mg)', 'armGroupLabels': ['Placebo (TA-8995 1mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (TA-8995 2.5mg)', 'armGroupLabels': ['Placebo (TA-8995 2.5mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (TA-8995 5mg)', 'armGroupLabels': ['Placebo (TA-8995 5mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (TA-8995 10mg)', 'armGroupLabels': ['Placebo (TA-8995 10mg)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (TA-8995 25mg)', 'armGroupLabels': ['Placebo (TA-8995 25mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22769', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Momentum Pharma Services GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Werner Weber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Momentum Pharma Services GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}