Clinical Trials Directory

Trials / Completed

CompletedNCT03802786

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
Phase
Phase 1
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Poxel SA · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DRUGImegliminSingle administration dose of imeglimin

Timeline

Start date
2018-11-06
Primary completion
2019-07-03
Completion
2019-07-08
First posted
2019-01-14
Last updated
2020-08-11

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03802786. Inclusion in this directory is not an endorsement.