Pharmacokinetics in End Stage Renal Disease Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Healthy Volunteers
• Intervention / Treatment: Drug: firibastat

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Gières, France, 38610
    • Eurofins Optimed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: QGC001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Quantum Genomics SA
• Collaborators: Eurofins Optimed

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2019
• Primary Completion (ACTUAL): July 10, 2020
• Study Completion (ACTUAL): July 10, 2020

Study Registration Dates

• First Submitted: December 26, 2019
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Antihypertensive Agents; Firibastat
• Other Study ID Numbers: QGC001-1QG4; 2019-001817-18 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No