Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05607173 | A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment | PHASE1 | COMPLETED | 21 | — | — | Jan 18, 2023 | May 3, 2023 | Sep 19, 2025 | 2 | Bulgaria, France |
Maximum plasma concentration observed (Cmax)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
| Arm | Type | Description |
|---|---|---|
| Participants with mild HI | EXPERIMENTAL | Mild HI is defined as a total score ranging from 5 to 6, inclusive (Child-Pugh score A) |
| Participants with moderate HI | EXPERIMENTAL | Moderate HI is defined as a total score ranging from 7 to 9, inclusive (Child-Pugh score B) |
| Participants with normal hepatic function | EXPERIMENTAL | Participants with normal hepatic function matched to participants |
| Name | Type | Description |
|---|---|---|
| Fexinidazole (HOE239) | DRUG | Route of administration: oral; pharmaceutical form: tablet |
Inclusion Criteria: * Male or female participants, between 18 and 75 years of age, inclusive * 12-lead ECG without clinically significant abnormality, in the judgment of the Investigator; normal QT interval confirmed * Contraception (with double contraception methods) for male and female (unless po...