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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: Imeglimin

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany
    • APEX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate hepatic impairment; Single dose of Imeglimin	Drug: Imeglimin; Single administration dose of imeglimin
Experimental: Normal hepatic function; Single dose of Imeglimin	Drug: Imeglimin; Single administration dose of imeglimin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Poxel SA
• Investigators: Study Director: Clémence Chevalier, Poxel SA

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): July 3, 2019
• Study Completion (Actual): July 8, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pharmacokinetics
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: PXL008-024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No