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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03802786

Enrollment

Registered

2019-01-14

Start date

2018-11-06

Completion date

2019-07-08

Last updated

2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

pharmacokinetics

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.

Interventions

DRUGImeglimin

Single administration dose of imeglimin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
PK parameters of imeglimin	At Day 1	Cmax: peak plasma concentration after dosing

Secondary

Measure	Time frame	Description
PK parameters of imeglimin	From day 1 to day 2	AUC last:area under the concentration-time curve
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	From day 1 to day 7	Incidence of Treatment-Emergent Adverse Events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026