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Pharmacokinetics in End Stage Renal Disease Patients

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ClinicalTrials.gov Identifier: NCT04792333
Recruitment Status : Completed
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Eurofins Optimed
Information provided by (Responsible Party):
Quantum Genomics SA

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Renal Failure Drug: firibastat Phase 1

Detailed Description:

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).

Subjects 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.

A follow-up post study visit will occur on Day 10 post-dose to ensure the ongoing wellbeing of the subjects.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 17, 2019
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
500 mg (2 capsules of 250 mg)
 Drug: firibastat
Single oral dose of 500 mg administration on Day 1
Other Name: QGC001


Outcome Measures
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Primary Outcome Measures :
  1. Firibastat and metabolites Concentrations [ Time Frame: Day 1 to Day 3 ]
    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)


Secondary Outcome Measures :
  1. Systolic and Diastolic Blood Pressure (mmHg) [ Time Frame: Day 1 to Day 3 ]
    Systolic and Diastolic blood pressure

  2. Heart Rate (bpm) [ Time Frame: Day 1 to Day 3 ]
    number of beats per minute

  3. Hematology blood sample laboratory tests aggregated as number of patients outside ranges [ Time Frame: Day 1 to Day 3 ]
    Hemoglobin, Hematocrit, MCH, MCHC, MCV, MPV, RBC (erythrocytes), WBC (Leucocytes), Differential Count (Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Large Unstained cells), Platelets.

  4. Biochemistry blood sample laboratory tests aggregated as number of patients outside ranges [ Time Frame: Day 1 to Day 3 ]
    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.

  5. Hemostasis blood sample laboratory tests aggregated as number of patients outside ranges [ Time Frame: Day 1 to Day 3 ]
    INR, PT, aPTT

  6. Urinalysis tests aggregated as number of patients outside ranges [ Time Frame: Day 1 to Day 3 ]
    pH, ketone bodies, proteins, glucose, occult blood, blood leukocytes, nitrite, bilirubin, urobilinogen, density.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects, aged 18 to 55 years inclusive;
  • Non-smoker subject or smoker of not more than 5 cigarettes a day;

Exclusion Criteria:

  • 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);
  • History or presence of drug or alcohol abuse (alcohol consumption > 40 grams/day);
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792333


Locations
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France
Eurofins Optimed
Gières, France, 38610
Sponsors and Collaborators
Quantum Genomics SA
Eurofins Optimed
Investigators
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Principal Investigator: Yves DONAZZOLO, MD Eurofins Optimed
More Information
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Responsible Party: Quantum Genomics SA
ClinicalTrials.gov Identifier: NCT04792333    
Other Study ID Numbers: QGC001-1QG4
2019-001817-18 ( EudraCT Number )
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Firibastat
Antihypertensive Agents