Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT01551602
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2012-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of AK159 in Healthy Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-21', 'studyFirstSubmitDate': '2012-03-01', 'studyFirstSubmitQcDate': '2012-03-12', 'lastUpdatePostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC) of teriparatide', 'timeFrame': 'up to 6 hours after single and repeated administration'}, {'measure': 'Peak Plasma Concentration (Cmax) of teriparatide', 'timeFrame': 'up to 6 hours after single and repeated administration'}, {'measure': 'Number of Participants with Adverse Events, Vital signs, ECG parameters, and 24-hour ECG holter recording (for Part 2 of the study).', 'timeFrame': 'up to 24 hours after single and repeated administration'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in bone turnover markers within 24 hrs at each administration'}, {'measure': 'Residual teriparatide in the patch after application'}]}, 'conditionsModule': {'keywords': ['AK159', 'teriparatide acetate'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the pharmacokinetics, safety, and tolerability of AK159 administered to healthy postmenopausal women.', 'detailedDescription': 'This study consists of Part 1 and Part 2. \\<Part 1\\> Part 1 will be conducted according to a single-centre, randomized, single-dose, 3-period, 5-treatment alternating crossover design in two groups of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of a single dose of AK159 (4 levels) will be investigated versus teriparatide acetate for injection as a control.\n\n\\<Part 2\\> Part 2 will be conducted according to a multiple-centre, randomized, double-blind, placebo-controlled, repeated dose parallel design of healthy post-menopausal women The pharmacokinetics, safety, and tolerability of AK159 (4 levels) for 8 weeks will be investigated versus teriparatide acetate for injection and placebo as controls. Pharmacokinetics, safety, and tolerability following long-term application will also be investigated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy postmenopausal ethnic Japanese women; At least 45 years of age at the time consent is obtained; and Give voluntary consent in writing with a sufficient understanding of the study.\n\nExclusion Criteria:\n\n* Clinical abnormality identified in the laboratory tests\n* Weight \\< 40.0 kg\n* Body mass index \\< 17.5 or \\>=30.5\n* History of disease of the kidneys, liver, heart, brain, or other organ that makes them ineligible as subjects\n* Previously received radiation treatment potentially affecting bone\n* Systolic blood pressure \\< 90 mmHg\n* QTc exceeds 470 msec in a 12-lead electrocardiography\n* Serum calcium level exceeding 10.4 mg/dL\n* History of contact dermatitis or skin disease potentially compromising study evaluation\n* Used drugs which impact bone metabolism in the 8-week period preceding investigational product administration\n* Used a bisphosphonate;\n* Used a teriparatide product;'}, 'identificationModule': {'nctId': 'NCT01551602', 'briefTitle': 'Clinical Study of AK159 in Healthy Postmenopausal Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asahi Kasei Pharma Corporation'}, 'orgStudyIdInfo': {'id': 'AK159 I-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK159 SD 1', 'description': 'Single administration of AK159 dose level 1', 'interventionNames': ['Drug: AK159']}, {'type': 'EXPERIMENTAL', 'label': 'AK159 SD 2', 'description': 'Single administration of AK159 dose level 2', 'interventionNames': ['Drug: AK159']}, {'type': 'EXPERIMENTAL', 'label': 'AK159 SD 3', 'description': 'Single administration of AK159 dose level 3', 'interventionNames': ['Drug: AK159']}, {'type': 'EXPERIMENTAL', 'label': 'AK159 SD 4', 'description': 'Single administration of AK159 dose level 4', 'interventionNames': ['Drug: AK159']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MN-10-T SD', 'description': 'Single administration of MN-10-T', 'interventionNames': ['Drug: MN-10-T']}, {'type': 'EXPERIMENTAL', 'label': 'AK159 MD 1', 'description': 'Multiple administration of AK159 dose level 1', 'interventionNames': ['Drug: AK159']}, {'type': 'EXPERIMENTAL', 'label': 'AK159 MD 2', 'description': 'Multiple administration of AK159 dose level 2', 'interventionNames': ['Drug: AK159']}, {'type': 'EXPERIMENTAL', 'label': 'AK159 MD 3', 'description': 'Multiple administration of AK159 dose level 3', 'interventionNames': ['Drug: AK159']}, {'type': 'EXPERIMENTAL', 'label': 'AK159 MD 4', 'description': 'Multiple administration of AK159 dose level 4', 'interventionNames': ['Drug: AK159']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MN-10-T MD', 'description': 'Multiple administration of MN-10-T', 'interventionNames': ['Drug: MN-10-T']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MD', 'description': 'Multiple administration of placebo AK159', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AK159', 'type': 'DRUG', 'description': 'transdermal administration of teriparatide acetate', 'armGroupLabels': ['AK159 MD 1', 'AK159 MD 2', 'AK159 MD 3', 'AK159 MD 4', 'AK159 SD 1', 'AK159 SD 2', 'AK159 SD 3', 'AK159 SD 4']}, {'name': 'MN-10-T', 'type': 'DRUG', 'description': 'subcutaneous administration of teriparatide acetate', 'armGroupLabels': ['MN-10-T MD', 'MN-10-T SD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Multiple administration of placebo AK159', 'armGroupLabels': ['Placebo MD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asahi Kasei Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}