Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-02-20 @ 6:35 PM
Study NCT ID:
NCT02373150
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2015-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
Sponsor:
Poxel SA
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: