Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-03 @ 2:19 PM
Study NCT ID:
NCT04792333
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2019-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics in End Stage Renal Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C528573', 'term': 'firibastat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2019-12-26', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Firibastat and metabolites Concentrations', 'timeFrame': 'Day 1 to Day 3', 'description': 'The plasma concentration data for firibastat (QGC001), EC33 and QGC515, will be analysed at each time measurement (predose, 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48 hours post-dose)'}], 'secondaryOutcomes': [{'measure': 'Systolic and Diastolic Blood Pressure (mmHg)', 'timeFrame': 'Day 1 to Day 3', 'description': 'Systolic and Diastolic blood pressure'}, {'measure': 'Heart Rate (bpm)', 'timeFrame': 'Day 1 to Day 3', 'description': 'number of beats per minute'}, {'measure': 'Hematology blood sample laboratory tests aggregated as number of patients outside ranges', 'timeFrame': 'Day 1 to Day 3', 'description': 'Hemoglobin, Hematocrit, MCH, MCHC, MCV, MPV, RBC (erythrocytes), WBC (Leucocytes), Differential Count (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Large Unstained cells), Platelets.'}, {'measure': 'Biochemistry blood sample laboratory tests aggregated as number of patients outside ranges', 'timeFrame': 'Day 1 to Day 3', 'description': 'Albumin, Alkaline Phosphatase, ALT, Amylase, AST, Bicarbonate, Bilirubin (direct, indirect and total), Calcium, Chloride, Cholesterol, Creatinine Kinase, Creatinine, gammaGT, HDLcholesterol, LDH, LDL - cholesterol, Lipase, Magnesium, Phosphate, Potassium, Protein total, Sodium, Triglycerides, Urea, Uric Acid, Glucose.'}, {'measure': 'Hemostasis blood sample laboratory tests aggregated as number of patients outside ranges', 'timeFrame': 'Day 1 to Day 3', 'description': 'INR, PT, aPTT'}, {'measure': 'Urinalysis tests aggregated as number of patients outside ranges', 'timeFrame': 'Day 1 to Day 3', 'description': 'pH, ketone bodies, proteins, glucose, occult blood, blood leukocytes, nitrite, bilirubin, urobilinogen, density.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers', 'Renal Failure']}, 'descriptionModule': {'briefSummary': 'The study is a multicentre, open label, phase I, two arms study to compare pharmacokinetic of firibastat after a single oral dose of firibastat 500 mg in fourteen healthy male volunteers and in fourteen End Stage Renal Disease (ESRD) patients not yet in dialysis.', 'detailedDescription': 'It is planned to enroll a total of 28 subjects to receive a single oral dose of investigational medicinal product (IMP): 14 ESRD patients will be enrolled in three Hungarian centres (1st arm) and 14 Healthy volunteers will be enrolled by Eurofins Optimed in Gières, France (2nd arm).\n\nSubjects will be screened for eligibility to participate in the study up to 21 days prior to the first administration. For both arm, subjects will be admitted into the Clinical Research Unit (CRU) on Day -3. On the morning of Day 1, subjects will receive a single 500 mg oral dose of firibastat following an overnight fast (i.e., at least 10 hours). Subjects will be confined to the CRU until discharge on Day 3 with PK blood sample draws for measurement of firibastat and its main metabolites being taken throughout the confinement.\n\nA follow-up post study visit will occur on Day 10 post-dose to ensure the ongoing wellbeing of the subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects, aged 18 to 55 years inclusive;\n* Non-smoker subject or smoker of not more than 5 cigarettes a day;\n\nExclusion Criteria:\n\n* Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody, or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests);\n* History or presence of drug or alcohol abuse (alcohol consumption \\> 40 grams/day);'}, 'identificationModule': {'nctId': 'NCT04792333', 'briefTitle': 'Pharmacokinetics in End Stage Renal Disease Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quantum Genomics SA'}, 'officialTitle': 'A Phase I Study to Compare Pharmacokinetic Parameters of Firibastat and Its Metabolites (EC33 and QGC515) in Healthy Subjects Versus End Stage Renal Disease (ESRD) Patients After a Single Oral Administration of Firibastat 500 mg', 'orgStudyIdInfo': {'id': 'QGC001-1QG4'}, 'secondaryIdInfos': [{'id': '2019-001817-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': '500 mg (2 capsules of 250 mg)', 'interventionNames': ['Drug: firibastat']}], 'interventions': [{'name': 'firibastat', 'type': 'DRUG', 'otherNames': ['QGC001'], 'description': 'Single oral dose of 500 mg administration on Day 1', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38610', 'city': 'Gières', 'country': 'France', 'facility': 'Eurofins Optimed', 'geoPoint': {'lat': 45.17997, 'lon': 5.78935}}], 'overallOfficials': [{'name': 'Yves DONAZZOLO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eurofins Optimed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quantum Genomics SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eurofins Optimed', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}