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.
Combined single and repeated dose groups with 3 escalating doses
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Hammersmith Medicines Research (HMR)
London, United Kingdom
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
Time frame: 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
Time frame: From baseline to Day 13
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