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Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Imeglimin
Placebo
Sponsored by
Poxel SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Hammersmith Medicines Research (HMR)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A1

Group A2

Group A3

Arm Description

Dose 1 or placebo

Dose 2 or placebo

Dose 3 or placebo

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Full Information

First Posted
February 2, 2015
Last Updated
February 9, 2017
Sponsor
Poxel SA
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1. Study Identification

Unique Protocol Identification Number
NCT02373150
Brief Title
Safety, Tolerability and PK of Imeglimin in Japanese Volunteers
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poxel SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A1
Arm Type
Experimental
Arm Description
Dose 1 or placebo
Arm Title
Group A2
Arm Type
Experimental
Arm Description
Dose 2 or placebo
Arm Title
Group A3
Arm Type
Experimental
Arm Description
Dose 3 or placebo
Intervention Type
Drug
Intervention Name(s)
Imeglimin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
From baseline to Day 13
Title
Safety and tolerability of imeglimin: laboratory assessments
Description
routine hematology, biochemistry, coagulation and urinalysis physical examination 12-lead ECG vital signs capillary glucose incidence of adverse events
Time Frame
From baseline to Day 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Hammersmith Medicines Research (HMR)
City
London
Country
United Kingdom

12. IPD Sharing Statement

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Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

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