Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

Poxel

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Imeglimin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03802786

PXL008-024

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Moderate hepatic impairment

Experimental group

Description:

Single dose of Imeglimin

Treatment:

Drug: Imeglimin

Normal hepatic function

Experimental group

Description:

Single dose of Imeglimin

Treatment:

Drug: Imeglimin