Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-06 @ 12:12 PM
Study NCT ID:
NCT02796118
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2016-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C568714', 'term': 'ASP2151'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of ASP2151 in plasma: Cmax', 'timeFrame': 'Up to Day 9', 'description': 'Cmax: Maximum concentration'}, {'measure': 'Pharmacokinetics of ASP2151 in plasma: tmax', 'timeFrame': 'Up to Day 9', 'description': 'tmax: The time after dosing when Cmax occurs'}, {'measure': 'Pharmacokinetics of ASP2151 in plasma: t1/2', 'timeFrame': 'Up to Day 9', 'description': 't1/2: Apparent terminal elimination half-life'}, {'measure': 'Pharmacokinetics of ASP2151 in plasma: C24', 'timeFrame': 'Up to Day 9', 'description': 'C24: Concentration at 24hours after dosing'}, {'measure': 'Pharmacokinetics of ASP2151 in plasma: AUC24', 'timeFrame': 'Up to Day 9', 'description': 'AUC24: Area under the concentration-time curve from the time of dosing to 24hours after dosing'}, {'measure': 'Pharmacokinetics of ASP2151 in plasma: AUCinf', 'timeFrame': 'Up to Day 9', 'description': 'AUCinf: Area under the concentration-time curve from the time of dosing extrapolated to time infinity'}, {'measure': 'Pharmacokinetics of ASP2151 in plasma: CL/F', 'timeFrame': 'Up to Day 9', 'description': 'CL/F: Apparent total systemic clearance'}, {'measure': 'Pharmacokinetics of ASP2151 in urine: Ae', 'timeFrame': 'Up to Day 9', 'description': 'Ae: Amount excreted in urine'}, {'measure': 'Pharmacokinetics of ASP2151 in urine: Cumulative Ae', 'timeFrame': 'Up to Day 9'}, {'measure': 'Pharmacokinetics of ASP2151 in urine: Ae%', 'timeFrame': 'Up to Day 9', 'description': 'Ae%: Percent of ASP2151 amount excreted in urine'}, {'measure': 'Pharmacokinetics of ASP2151 in urine: Cumulative Ae%', 'timeFrame': 'Up to Day 9'}, {'measure': 'Pharmacokinetics of ASP2151 in urine: CLR', 'timeFrame': 'Up to Day 9', 'description': 'CLR: Renal clearance'}, {'measure': 'Safety assessed by laboratory test: Hematology', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by laboratory test: blood biochemistry', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by laboratory test: urinalysis', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by Vital sign measurement: axillary body temperature', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by vital sign measurement: supine blood pressure', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by vital sign measurement: supine pulse rate', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by Standard 12-lead electrocardiogram', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by Standard 12-lead electrocardiogram for QT assessment', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by ophthalmological examination', 'timeFrame': 'Up to Day 14'}, {'measure': 'Safety assessed by incidence of adverse events', 'timeFrame': 'Up to Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Healthy non-elderly and elderly subjects', 'ASP2151', 'Safety'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '29134426', 'type': 'DERIVED', 'citation': 'Kusawake T, Keirns JJ, Kowalski D, den Adel M, Groenendaal-van de Meent D, Takada A, Ohtsu Y, Katashima M. Pharmacokinetics and Safety of Amenamevir in Healthy Subjects: Analysis of Four Randomized Phase 1 Studies. Adv Ther. 2017 Dec;34(12):2625-2637. doi: 10.1007/s12325-017-0642-4. Epub 2017 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and the pharmacokinetics of ASP2151 after multiple oral dosing of ASP2151 in healthy non-elderly male and elderly male Japanese subjects, and to compare the pharmacokinetics of ASP2151 in healthy non-elderly male and elderly male Japanese subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight: ≥50.0 kg and \\<85.0 kg\n* Body mass index (BMI): ≥17.6 and \\<26.4 kg/m2\n\nExclusion Criteria:\n\n* Subjects with a complication of any diseases\n* Subjects with a history of hepatic disease\n* Subjects with a history of heart disease\n* Subjects with a history of respiratory disease\n* Subjects with a history of alimentary disease\n* Subjects with a history of renal disease\n* Subjects with a history of cerebrovascular disorder\n* Subjects with a history of malignant tumor\n* Subjects with a history of drug allergies or allergies disorders excluding pollinosis\n* Subjects with a history of drug dependency or alcohol dependence syndrome\n* Subjects who developed genital herpes or herpes zoster within 90 days before the initial dosing\n* Subjects who do not meet any of the criteria for laboratory tests\n* Subjects who received medications within 14 days before the initial dosing.\n* Subjects who received any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening or the initial dosing\n* Excessive alcohol drinking or smoking habit\n* Subjects who previously received administration of ASP2151 (including placebo)\n* Abnormalities detected on an ophthalmological examination\n* Subjects who deviate from the normal range of standard 12-lead ECG at screening'}, 'identificationModule': {'nctId': 'NCT02796118', 'briefTitle': 'Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'ASP2151 Phase 1 Study - Multiple Oral Dosing Study in Healthy Non-elderly Male and Elderly Male Japanese Subjects-', 'orgStudyIdInfo': {'id': '15L-CL-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASP2151 Low dose in non-elderly subjects group', 'description': 'Subjects will receive ASP2151 daily on Days 1 to 7.', 'interventionNames': ['Drug: ASP2151']}, {'type': 'EXPERIMENTAL', 'label': 'ASP2151 High dose in non-elderly subjects group', 'description': 'Subjects will receive ASP2151 daily on Days 1 to 7.', 'interventionNames': ['Drug: ASP2151']}, {'type': 'EXPERIMENTAL', 'label': 'ASP2151 Low dose in elderly subjects group', 'description': 'Subjects will receive ASP2151 daily on Days 1 to 7.', 'interventionNames': ['Drug: ASP2151']}, {'type': 'EXPERIMENTAL', 'label': 'ASP2151 High dose in elderly subjects group', 'description': 'Subjects will receive ASP2151 daily on Days 1 to 7.', 'interventionNames': ['Drug: ASP2151']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo in non-elderly subjects group', 'description': 'Subjects will receive matching placebo daily on Days 1 to 7.', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo in elderly subjects group', 'description': 'Subjects will receive matching placebo daily on Days 1 to 7.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASP2151', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['ASP2151 High dose in elderly subjects group', 'ASP2151 High dose in non-elderly subjects group', 'ASP2151 Low dose in elderly subjects group', 'ASP2151 Low dose in non-elderly subjects group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral', 'armGroupLabels': ['Placebo in elderly subjects group', 'Placebo in non-elderly subjects group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Site JP00001', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}