Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-04-22 @ 3:24 AM
Study NCT ID:
NCT02189733
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2014-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C585343', 'term': 'caplacizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-11-13', 'studyFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2014-07-11', 'lastUpdatePostDateStruct': {'date': '2014-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: concentration of caplacizumab in plasma', 'timeFrame': 'Day 1 (pre-dose) until Day 7'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics as measured by Ristocetin cofactor activity in plasma', 'timeFrame': 'During screening until day 29 +/-1'}, {'measure': 'Safety and Tolerability: safety markers', 'timeFrame': 'From signing of informed consent form until day 43 +/- 2', 'description': 'Adverse events, local tolerability, laboratory assessments, urinalysis, vital signs, 12-lead ECG, physical examinations'}, {'measure': 'Pharmacodynamics as measured by von Willebrand factor antigen in plasma', 'timeFrame': 'During screening until Day 29 +/- 1'}, {'measure': 'Pharmacodynamics as measured by Factor VIII clotting activity in plasma', 'timeFrame': 'During screening until day 29 +/- 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to an equal nominal s.c. dose of the reference liquid formulation of caplacizumab.\n\nThe secondary objective of the study is to compare the safety and tolerability, and the pharmacodynamic parameters of the new formulation with those of the reference formulation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male Caucasians aged 18 to 55 years, inclusive.\n* Body weight 55 - 100 kg and body mass index (BMI) between 18.5 and 30.0, extremes included.\n* Coagulation and bleeding diathesis variables (as defined in the protocol) within the normal range at screening and on Day -1.\n* Others as defined in the protocol.\n\nExclusion Criteria:\n\n* History or presence of diseases in the kidneys and/or heart, lungs, liver, skin, endocrine organs or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.\n* History of and/or any sign or symptom indicating current abnormal hemostasis or blood dyscrasia.\n* Others as defined in the protocol'}, 'identificationModule': {'nctId': 'NCT02189733', 'briefTitle': 'Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ablynx, a Sanofi company'}, 'officialTitle': 'A Phase I, Single Center, Open-Label, Randomized, Single Dose Cross-Over Study in Healthy Male Subjects to Investigate the Bioequivalence and Tolerability of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.', 'orgStudyIdInfo': {'id': 'ALX0681-C102'}, 'secondaryIdInfos': [{'id': '2014-001294-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caplacizumab - Treatment A', 'description': 'Single s.c. dose of reconstituted lyophilized solution of caplacizumab followed by single s.c. dose of liquid formulation of caplacizumab', 'interventionNames': ['Biological: Caplacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Caplacizumab - Treatment B', 'description': 'Single s.c. dose of liquid formulation of caplacizumab followed by single s.c. dose of reconstituted lyophilized solution of caplacizumab', 'interventionNames': ['Biological: Caplacizumab']}], 'interventions': [{'name': 'Caplacizumab', 'type': 'BIOLOGICAL', 'description': 'Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab', 'armGroupLabels': ['Caplacizumab - Treatment A', 'Caplacizumab - Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Jean-Michel Paillarse, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ablynx, a Sanofi company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ablynx, a Sanofi company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}