A Multicentric, Open-label, Non-randomized, Pharmacokinetic and Tolerability Study of Fexinidazole Given as an Oral Single 1200 mg Dose in Participants With Mild and Moderate Hepatic Impairment, and in Matched Participants With Normal Hepatic Function
Sponsor study identifier
Secondary identifiers
REGISTRY · ICTRP
EUDRACT_NUMBER
interventional
21
2 countries
2
Study Start
January 18, 2023
Actual (reported)Primary Completion
May 3, 2023
Actual (reported)Study Completion
May 3, 2023
Actual (reported)In human, metabolic hepatic clearance represents a significant part of the total clearance of fexinidazole and could be decreased in patients with liver impairment, leading to some overexposure, and conversely, the formation of the 2 active metabolites could be decreased, leading to decreased exposure in hepatic impairment (HI). As there is no experience of use in patients with hepatic impairment, in fexinidazole summary of product characteristics (SmPC) approved by the European Medicines Agency (EMA), fexinidazole is contra-indicated in patients with clinical signs of cirrhosis or jaundice, and in the proposed USA product information, fexinidazole is contra-indicated in patients with liver impairment. Therefore, FDA requested a study with the objective to evaluate the effect of mild and moderate hepatic impairment (HI) on the pharmacokinetics (PK) of fexinidazole and its 2 metabolites, as a post-marketing requirement.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 3, 2023
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.
October 31, 2022
Actual (reported)November 7, 2022
Actual (reported)January 18, 2023
Actual (reported)May 3, 2023
Actual (reported)May 3, 2023
Actual (reported)Cmax for fexinidazole and metabolites M1, M2
Maximum plasma concentration observed (Cmax)
Day 1 to Day 6
AUC for fexinidazole and metabolites M1, M2
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Day 1 to Day 6
tmax for fexinidazole and metabolites M1, M2
Day 1 to Day 6
Fexinidazole unbound fraction
Day 1 and Day 2
Fexinidazole unbound Cmaxu
Day 1 and Day 6
Fexinidazole unbound AUCu
Day 1 and Day 6
Number of subjects with Adverse Events (AEs)
Day 1 to Day 10
Mild HI is defined as a total score ranging from 5 to 6, inclusive (Child-Pugh score A)
Moderate HI is defined as a total score ranging from 7 to 9, inclusive (Child-Pugh score B)
Participants with normal hepatic function matched to participants
Route of administration: oral; pharmaceutical form: tablet
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Investigational Site Number: 100-0001
Sofia, 1612, Bulgaria
Investigational site 250-0001
Rennes, France
Clinical Sciences & Operations
Sanofi
21 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2022
First Posted
November 7, 2022
Study Start
January 18, 2023
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
May 3, 2023
Actual (reported)Study Completion
May 3, 2023
Actual (reported)Last Updated
September 19, 2025
Record last verified: 2025-09
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Source: ClinicalTrials.gov.
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