NCT05607173

A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The duration of the study for 1 participant will be of 38 days maximum, including: * A screening period from Day (D)-28 to D-2 * Baseline assessments on D-1 * Single dose administration on D1 and institutionalization for 6 days * End of study (EOS): D10, or to be organized as soon as possible in case of early withdrawal

Conditions

• Hepatic Function Abnormal

Interventions

Type	Name	Description
DRUG	Fexinidazole (HOE239)	Route of administration: oral; pharmaceutical form: tablet

Timeline

• Start date: 2023-01-18
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2022-11-07
• Last updated: 2025-09-19

Locations

2 sites across 2 countries: Bulgaria, France

Regulatory

• FDA-regulated drug study