Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

NCT03802786 | Completed Phase 1

• 1 other identifier: PXL008-024
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Impairment

Keywords

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• PK parameters of imeglimin

  Cmax: peak plasma concentration after dosing

  At Day 1

Secondary Outcomes (2)

• PK parameters of imeglimin

  From day 1 to day 2

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From day 1 to day 7

Study Arms (2)

Moderate hepatic impairment

EXPERIMENTAL

Single dose of Imeglimin

Drug: Imeglimin

Normal hepatic function

EXPERIMENTAL

Single dose of Imeglimin

Drug: Imeglimin

Interventions

Imeglimin DRUG

Single administration dose of imeglimin

Moderate hepatic impairment; Normal hepatic function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Positive test for HBV, HBC
• eGFR less than 90 mL/min/1.73 m2
• liver diseases
• 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

Sponsors & Collaborators

• Poxel SA: lead

Study Sites (1)

Apex

Munich, Germany

Location

MeSH Terms

Interventions

imeglimin

Study Officials

• Clémence Chevalier

  Poxel SA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 14, 2019
• Study Start: November 6, 2018
• Primary Completion: July 3, 2019
• Study Completion: July 8, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

DE (1)