Pharmacokinetics in End Stage Renal Disease Patients

• Status: Completed
• Trial end date: 2020-07-10
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Quantum Genomics SA
• Collaborator: Eurofins Optimed
• Treatments: Firibastat

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);