Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03802786
• Other study ID #: PXL008-024
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2018
• Est. completion date: July 8, 2019

Study information

• Verified date: August 2020
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 8, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Imeglimin
Single administration dose of imeglimin

Locations

Country	Name	City	State
Germany	Apex	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Poxel SA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters of imeglimin	Cmax: peak plasma concentration after dosing	At Day 1
Secondary	PK parameters of imeglimin	AUC last:area under the concentration-time curve	From day 1 to day 2
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events	From day 1 to day 7