Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-13 @ 8:33 PM
Study NCT ID:
NCT02634034
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2015-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-08', 'studyFirstSubmitDate': '2015-12-10', 'studyFirstSubmitQcDate': '2015-12-14', 'lastUpdatePostDateStruct': {'date': '2016-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve', 'timeFrame': '0 to 48 hours', 'description': 'Area Under the Curve 0 to tau'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject provides written informed consent before any study-specific evaluation is performed.\n* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.\n* Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator.\n* Subject is able and willing to comply with the protocol and study procedures.\n\nExclusion Criteria:\n\n* Subject is a woman who is pregnant or breastfeeding.\n* Subject has clinically relevant abnormalities in the screening or check-in assessments.\n* Subject has received an investigational drug within 30 days before the first dose of study drug.'}, 'identificationModule': {'nctId': 'NCT02634034', 'briefTitle': 'A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'orgStudyIdInfo': {'id': 'NK-104-CR-1.01US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)', 'interventionNames': ['Drug: A: NK-104-CR 8 mg', 'Drug: B: Pitavastatin IR 4 mg', 'Drug: C: Pitavastatin IR 8 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)', 'interventionNames': ['Drug: A: NK-104-CR 8 mg', 'Drug: B: Pitavastatin IR 4 mg', 'Drug: C: Pitavastatin IR 8 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)', 'interventionNames': ['Drug: A: NK-104-CR 8 mg', 'Drug: B: Pitavastatin IR 4 mg', 'Drug: C: Pitavastatin IR 8 mg']}], 'interventions': [{'name': 'A: NK-104-CR 8 mg', 'type': 'DRUG', 'description': 'NK-104-CR 8 mg (Controlled Release single 8-mg tablet)', 'armGroupLabels': ['NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)', 'Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)', 'Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)']}, {'name': 'B: Pitavastatin IR 4 mg', 'type': 'DRUG', 'description': 'Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)', 'armGroupLabels': ['NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)', 'Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)', 'Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)']}, {'name': 'C: Pitavastatin IR 8 mg', 'type': 'DRUG', 'description': 'Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)', 'armGroupLabels': ['NK-104-CR (8mg), Pitavastatin IR (4mg), Pitavastatin IR (8mg)', 'Pitavastatin IR (4mg), Pitavastatin IR (8mg), NK-104-CR (8mg)', 'Pitavastatin IR (8mg), NK-104-CR (8mg), Pitavastatin IR (4mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowa Research Institute, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}