Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT02373150
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C575881', 'term': 'imeglimin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-09', 'studyFirstSubmitDate': '2015-02-02', 'studyFirstSubmitQcDate': '2015-02-25', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin', 'timeFrame': 'From baseline to Day 13', 'description': '* Cmax: peak plasma concentration after dosing\n* AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time\n* AUC0-t: area under the concentration-time curve from 0 to the time of last quantifiable concentration\n* Tmax: time of peak plasma concentration of imeglimin'}, {'measure': 'Safety and tolerability of imeglimin: laboratory assessments', 'timeFrame': 'From baseline to Day 13', 'description': '* routine hematology, biochemistry, coagulation and urinalysis\n* physical examination\n* 12-lead ECG\n* vital signs\n* capillary glucose\n* incidence of adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.', 'detailedDescription': 'Combined single and repeated dose groups with 3 escalating doses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female Japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine\n* Body mass index in the range 18.0-25.0 kg/m2\n* Willing to use reliable contraception\n* Able to give fully informed written consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception\n* Clinically relevant abnormal findings at the screening assessment\n* Clinically significant vital signs outside the acceptable range at screening\n* Clinically relevant abnormal medical history, surgery or concurrent medical condition\n* Acute or chronic illness\n* Estimated glomerular filtration rate less than 80 mL/min/1.73 m2\n* Severe adverse reaction to any drug or sensitivity to the trial medication or its components\n* Significant food allergy; vegetarian or vegan\n* Use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol \\[acetaminophen\\]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication\n* Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication\n* Drug or alcohol abuse\n* Smoking of more than 5 cigarettes daily\n* Possibility that subject will not cooperate\n* Positive test for hepatitis B \\& C, HIV\n* Objection by a General Practitioner.'}, 'identificationModule': {'nctId': 'NCT02373150', 'briefTitle': 'Safety, Tolerability and PK of Imeglimin in Japanese Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Poxel SA'}, 'officialTitle': 'A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects', 'orgStudyIdInfo': {'id': 'PXL008-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A1', 'description': 'Dose 1 or placebo', 'interventionNames': ['Drug: Imeglimin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group A2', 'description': 'Dose 2 or placebo', 'interventionNames': ['Drug: Imeglimin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group A3', 'description': 'Dose 3 or placebo', 'interventionNames': ['Drug: Imeglimin', 'Drug: Placebo']}], 'interventions': [{'name': 'Imeglimin', 'type': 'DRUG', 'armGroupLabels': ['Group A1', 'Group A2', 'Group A3']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Group A1', 'Group A2', 'Group A3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research (HMR)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poxel SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}