Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects

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.

Inclusion Criteria:

• Caucasian
• BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
• Stable hepatic impairment or normal hepatic function for healthy volunteer
• No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
• Informed consent signature

Exclusion Criteria:

• Clinically relevant abnormal findings at the screening assessment
• Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• Drug or alcohol abuse
• Positive test HIV
• Smoking more than 10 cig/day
• Participation in other clinical trials of unlicensed or prescription medicines

Exclusion criteria for healthy volunteer

• Positive test for HBV, HBC
• eGFR less than 90 mL/min/1.73 m2
• liver diseases

Exclusion criteria for hepatic impaired

• eGFR less than 80 mL/min/1.73 m2
• Hepatic impairment due to non liver disease
• History of hepatocellular carcinoma or acute liver disease
• CLinically significant change in liver disease status within 6 months
• ascites
• encephalopathy grade III or IV