Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hepatic Impairment

Intervention / Treatment
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* Drug: Imeglimin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate hepatic impairment<br>Single dose of Imeglimin | Drug: Imeglimin<br>* Single administration dose of imeglimin<br>|
| Experimental: Normal hepatic function<br>Single dose of Imeglimin | Drug: Imeglimin<br>* Single administration dose of imeglimin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of imeglimin | Cmax: peak plasma concentration after dosing | At Day 1 | 

Secondary Outcome Measures

| Outcome Measure | 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 | From day 1 to day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics