Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

Study Overview
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Brief Summary
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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
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Combined single and repeated dose groups with 3 escalating doses

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Imeglimin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Japanese subjects, deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine Body mass index in the range 18.0-25.0 kg/m2 Willing to use reliable contraception Able to give fully informed written consent. Exclusion Criteria: Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception Clinically relevant abnormal findings at the screening assessment Clinically significant vital signs outside the acceptable range at screening Clinically relevant abnormal medical history, surgery or concurrent medical condition Acute or chronic illness Estimated glomerular filtration rate less than 80 mL/min/1.73 m2 Severe adverse reaction to any drug or sensitivity to the trial medication or its components Significant food allergy; vegetarian or vegan Use of vitamins, herbal medicines, or over-the-counter medication (with the exception of paracetamol [acetaminophen]) within 7 days before first dose of trial medication, or prescribed medication during the 14 days before first dose of trial medication Participation in other clinical trials of unlicensed or prescription medicines, or loss of more than 400 mL blood, within the 3 months before first dose of trial medication Drug or alcohol abuse Smoking of more than 5 cigarettes daily Possibility that subject will not cooperate Positive test for hepatitis B & C, HIV Objection by a General Practitioner.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A1<br>Dose 1 or placebo | Drug: Imeglimin<br> <br> Drug: Placebo<br> <br> |
| Experimental: Group A2<br>Dose 2 or placebo | Drug: Imeglimin<br> <br> Drug: Placebo<br> <br> |
| Experimental: Group A3<br>Dose 3 or placebo | Drug: Imeglimin<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |