| Trial ID: | L3914 |
| Source ID: | NCT02373150
|
| Associated Drug: |
Imeglimin
|
| Title: |
Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Imeglimin|DRUG: Placebo
|
| Outcome Measures: |
Primary: PK parameters of imeglimin after single and repeated doses: - Cmax: peak plasma concentration after dosing, AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time, - Tmax: time of peak plasma concentration of imeglimin, * Cmax: peak plasma concentration after dosing * AUC0-∞: area under the concentration-time curve from 0 extrapolated to infinite time * AUC0-t: area under the concentration-time curve from 0 to the time of last quantifiable concentration * Tmax: time of peak plasma concentration of imeglimin, From baseline to Day 13|Safety and tolerability of imeglimin: laboratory assessments, * routine hematology, biochemistry, coagulation and urinalysis * physical examination * 12-lead ECG * vital signs * capillary glucose * incidence of adverse events, From baseline to Day 13 |
|
| Sponsor/Collaborators: |
Sponsor: Poxel SA
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-02
|
| Completion Date: |
2015-10
|
| Results First Posted: |
|
| Last Update Posted: |
2017-02-10
|
| Locations: |
Hammersmith Medicines Research (HMR), London, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02373150
|
