Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

NCT02373150 | Completed Phase 1

• 1 other identifier: PXL008-011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Group A1

EXPERIMENTAL

Dose 1 or placebo

Drug: Imeglimin; Drug: Placebo

Group A2

EXPERIMENTAL

Dose 2 or placebo

Drug: Imeglimin; Drug: Placebo

Group A3

EXPERIMENTAL

Dose 3 or placebo

Drug: Imeglimin; Drug: Placebo

Interventions

Imeglimin DRUG

Group A1; Group A2; Group A3

Placebo DRUG

Group A1; Group A2; Group A3

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poxel SA: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

imeglimin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: February 26, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

GB (1)