Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Poxel SA

Criteria

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.