Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

Poxel

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Imeglimin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02373150

PXL008-011

Details and patient eligibility

About

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.

Full description

Combined single and repeated dose groups with 3 escalating doses

Enrollment: 48 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups

Group A1

Experimental group

Description:

Dose 1 or placebo

Treatment:

Drug: Placebo

Drug: Imeglimin

Group A2

Experimental group

Description:

Dose 2 or placebo

Treatment:

Drug: Placebo

Drug: Imeglimin

Group A3

Experimental group

Description:

Dose 3 or placebo

Treatment:

Drug: Placebo

Drug: Imeglimin