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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

Tracking Information
First Submitted Date  ICMJE February 2, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE February 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Imeglimin
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Group A1
    Dose 1 or placebo
    Interventions:
    • Drug: Imeglimin
    • Drug: Placebo
  • Experimental: Group A2
    Dose 2 or placebo
    Interventions:
    • Drug: Imeglimin
    • Drug: Placebo
  • Experimental: Group A3
    Dose 3 or placebo
    Interventions:
    • Drug: Imeglimin
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 9, 2017)
48
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2015)
24
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02373150
Other Study ID Numbers  ICMJE PXL008-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Poxel SA
Study Sponsor  ICMJE Poxel SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Poxel SA
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP