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Clinical Trial Details

Trial ID: L1146
Source ID: NCT04792333
Associated Drug: Firibastat
Title: Pharmacokinetics in End Stage Renal Disease Patients
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy Volunteers|Renal Failure
Interventions: DRUG: firibastat
Outcome Measures: Primary: Firibastat and metabolites Concentrations, 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), Day 1 to Day 3 | Secondary: Systolic and Diastolic Blood Pressure (mmHg), Systolic and Diastolic blood pressure, Day 1 to Day 3|Heart Rate (bpm), number of beats per minute, Day 1 to Day 3|Hematology blood sample laboratory tests aggregated as number of patients outside ranges, Hemoglobin, Hematocrit, MCH, MCHC, MCV, MPV, RBC (erythrocytes), WBC (Leucocytes), Differential Count (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Large Unstained cells), Platelets., Day 1 to Day 3|Biochemistry blood sample laboratory tests aggregated as number of patients outside ranges, 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., Day 1 to Day 3|Hemostasis blood sample laboratory tests aggregated as number of patients outside ranges, INR, PT, aPTT, Day 1 to Day 3|Urinalysis tests aggregated as number of patients outside ranges, pH, ketone bodies, proteins, glucose, occult blood, blood leukocytes, nitrite, bilirubin, urobilinogen, density., Day 1 to Day 3
Sponsor/Collaborators: Sponsor: Quantum Genomics SA | Collaborators: Eurofins Optimed
Gender: MALE
Age: ADULT
Phases: PHASE1
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-09-17
Completion Date: 2020-07-10
Results First Posted:
Last Update Posted: 2021-03-10
Locations: Eurofins Optimed, Gières, 38610, France
URL: https://clinicaltrials.gov/show/NCT04792333