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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Single administration dose of imeglimin
Apex
Munich, Germany
PK parameters of imeglimin
Cmax: peak plasma concentration after dosing
Time frame: At Day 1
PK parameters of imeglimin
AUC last:area under the concentration-time curve
Time frame: From day 1 to day 2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events
Time frame: From day 1 to day 7
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