Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

• Status: Completed
• Trial end date: 2019-07-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Poxel SA

Criteria

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