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
2 other identifiers
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Sep 2019
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2019
CompletedFirst Submitted
Initial submission to the registry
December 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedMarch 10, 2021
March 1, 2021
10 months
December 26, 2019
March 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Systolic and Diastolic Blood Pressure (mmHg)
Day 1 to Day 3
Heart Rate (bpm)
Day 1 to Day 3
Hematology blood sample laboratory tests aggregated as number of patients outside ranges
Day 1 to Day 3
Biochemistry blood sample laboratory tests aggregated as number of patients outside ranges
Day 1 to Day 3
Hemostasis blood sample laboratory tests aggregated as number of patients outside ranges
Day 1 to Day 3
- +1 more secondary outcomes
Study Arms (1)
Treatment
EXPERIMENTAL500 mg (2 capsules of 250 mg)
Interventions
Eligibility Criteria
You may qualify if:
- Male subjects, aged 18 to 55 years inclusive;
- Non-smoker subject or smoker of not more than 5 cigarettes a day;
You may not qualify if:
- 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);
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Quantum Genomics SAlead
- Eurofins Optimedcollaborator
Study Sites (1)
Eurofins Optimed
Gières, 38610, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yves DONAZZOLO, MD
Eurofins Optimed
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2019
First Posted
March 10, 2021
Study Start
September 17, 2019
Primary Completion
July 10, 2020
Study Completion
July 10, 2020
Last Updated
March 10, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share