Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Imeglimin; Drug: Placebo

• Registration Number: NCT02373150
• Lead Sponsor: Poxel SA

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-02
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-02-26
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A1	Imeglimin	Dose 1 or placebo
Group A1	Placebo	Dose 1 or placebo
Group A2	Imeglimin	Dose 2 or placebo
Group A2	Placebo	Dose 2 or placebo
Group A3	Placebo	Dose 3 or placebo
Group A3	Imeglimin	Dose 3 or placebo

Primary Outcome Measures

Name	Time	Method
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	From baseline to Day 13	* 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
Safety and tolerability of imeglimin: laboratory assessments	From baseline to Day 13	* routine hematology, biochemistry, coagulation and urinalysis; * physical examination; * 12-lead ECG; * vital signs; * capillary glucose; * incidence of adverse events

Trial Locations

Locations (1)

Hammersmith Medicines Research (HMR); 🇬🇧 London, United Kingdom