Status:
COMPLETED
Pharmacokinetics in End Stage Renal Disease Patients
Lead Sponsor:
Quantum Genomics SA
Collaborating Sponsors:
Eurofins Optimed
Conditions:
Healthy Volunteers
Renal Failure
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 fourte...
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 H...
Eligibility Criteria
Inclusion
- Male subjects, aged 18 to 55 years inclusive;
- Non-smoker subject or smoker of not more than 5 cigarettes a day;
Exclusion
- 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);
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04792333
Start Date
September 17 2019
End Date
July 10 2020
Last Update
March 10 2021
Active Locations (1)
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1
Eurofins Optimed
Gières, France, 38610