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Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

Primary Purpose

Hepatic Impairment

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Imeglimin

About this trial

This is an interventional treatment trial for Hepatic Impairment focused on measuring pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Apex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Moderate hepatic impairment

Normal hepatic function

Arm Description

Single dose of Imeglimin

Outcomes

Primary Outcome Measures

PK parameters of imeglimin

Cmax: peak plasma concentration after dosing

Secondary Outcome Measures

PK parameters of imeglimin

AUC last:area under the concentration-time curve

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

Incidence of Treatment-Emergent Adverse Events

Full Information

NCT ID

NCT03802786

First Posted

January 10, 2019

Last Updated

August 10, 2020

Sponsor

Poxel SA

1. Study Identification

Unique Protocol Identification Number

NCT03802786

Brief Title

Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

November 6, 2018 (Actual)

Primary Completion Date

July 3, 2019 (Actual)

Study Completion Date

July 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Poxel SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Impairment

Keywords

pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Moderate hepatic impairment

Arm Type

Experimental

Arm Description

Single dose of Imeglimin

Arm Title

Normal hepatic function

Arm Type

Experimental

Arm Description

Single dose of Imeglimin

Intervention Type

Drug

Intervention Name(s)

Imeglimin

Intervention Description

Single administration dose of imeglimin

Primary Outcome Measure Information:

Title

PK parameters of imeglimin

Description

Cmax: peak plasma concentration after dosing

Time Frame

At Day 1

Secondary Outcome Measure Information:

Title

PK parameters of imeglimin

Description

AUC last:area under the concentration-time curve

Time Frame

From day 1 to day 2

Title

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

Description

Incidence of Treatment-Emergent Adverse Events

Time Frame

From day 1 to day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clémence Chevalier

Organizational Affiliation

Poxel SA

Official's Role

Study Director

Facility Information:

Facility Name

Apex

City

Munich

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

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