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This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate hepatic impairment | Experimental | Single dose of Imeglimin |
|
| Normal hepatic function | Experimental | Single dose of Imeglimin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imeglimin | Drug | Single administration dose of imeglimin |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of imeglimin | Cmax: peak plasma concentration after dosing | At Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of imeglimin | AUC last:area under the concentration-time curve | From day 1 to day 2 |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria for healthy volunteer
Exclusion criteria for hepatic impaired
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| Name | Affiliation | Role |
|---|---|---|
| Clémence Chevalier | Poxel SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apex | Munich | Germany |
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| ID | Term |
|---|---|
| C575881 | imeglimin |
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| From day 1 to day 7 |