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Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373150
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Imeglimin Drug: Placebo Phase 1

Detailed Description:
Combined single and repeated dose groups with 3 escalating doses

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A1
Dose 1 or placebo
Drug: Imeglimin
Drug: Placebo
Experimental: Group A2
Dose 2 or placebo
Drug: Imeglimin
Drug: Placebo
Experimental: Group A3
Dose 3 or placebo
Drug: Imeglimin
Drug: Placebo



Primary Outcome Measures :
  1. 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 [ Time Frame: 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

  2. Safety and tolerability of imeglimin: laboratory assessments [ Time Frame: From baseline to Day 13 ]
    • routine hematology, biochemistry, coagulation and urinalysis
    • physical examination
    • 12-lead ECG
    • vital signs
    • capillary glucose
    • incidence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373150


Locations
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United Kingdom
Hammersmith Medicines Research (HMR)
London, United Kingdom
Sponsors and Collaborators
Poxel SA
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Responsible Party: Poxel SA
ClinicalTrials.gov Identifier: NCT02373150    
Other Study ID Numbers: PXL008-011
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases