NCT02373150

Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Imeglimin in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Poxel SA · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.

Detailed description

Combined single and repeated dose groups with 3 escalating doses

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Imeglimin
DRUG	Placebo

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-02-26
• Last updated: 2017-02-10

Locations

1 site across 1 country: United Kingdom