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Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

NCT03802786 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-08-11

No results posted yet for this study

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

Interventions

DRUG

Imeglimin

Single administration dose of imeglimin

Sponsors & Collaborators

  • Poxel SA

    lead INDUSTRY

Principal Investigators

  • Clémence Chevalier · Poxel SA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-06
Primary Completion
2019-07-03
Completion
2019-07-08

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03802786 on ClinicalTrials.gov