Pharmacokinetics in End Stage Renal Disease Patients

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792333
• Other study ID #: QGC001-1QG4
• Secondary ID: 2019-001817-18
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2019
• Est. completion date: July 10, 2020

Study information

• Verified date: March 2021
• Source: Quantum Genomics SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 10, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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);

Related Conditions & MeSH terms

• Healthy Volunteers
• Kidney Failure, Chronic
• Renal Failure

Intervention

Drug:
• firibastat
Single oral dose of 500 mg administration on Day 1

Locations

Country	Name	City	State
France	Eurofins Optimed	Gières

Sponsors (2)

Lead Sponsor	Collaborator
Quantum Genomics SA	Eurofins Optimed

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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
Secondary	Heart Rate (bpm)	number of beats per minute	Day 1 to Day 3
Secondary	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
Secondary	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
Secondary	Hemostasis blood sample laboratory tests aggregated as number of patients outside ranges	INR, PT, aPTT	Day 1 to Day 3
Secondary	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