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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
28
1 country
1
Study Start
September 17, 2019
Actual (reported)Primary Completion
July 10, 2020
Actual (reported)Study Completion
July 10, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 17, 2019
Actual (reported)December 26, 2019
Actual (reported)July 10, 2020
Actual (reported)July 10, 2020
Actual (reported)March 10, 2021
Actual (reported)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
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
500 mg (2 capsules of 250 mg)
Single oral dose of 500 mg administration on Day 1
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eurofins Optimed
Gières, 38610, France
Yves DONAZZOLO, MD
Eurofins Optimed
28 participants (actual enrollment reported by the registry).
First Submitted
December 26, 2019
First Posted
March 10, 2021
Study Start
September 17, 2019
Actual (reported)A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RO7017773 in Healthy Participants
Contact the study team to confirm eligibility.
Primary Completion
July 10, 2020
Actual (reported)Study Completion
July 10, 2020
Actual (reported)Last Updated
March 10, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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