Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

February 9, 2017 updated by: Poxel SA

A Randomised, Double-blind, Placebo and Active Controlled Crossover Study to Assess the Effect of Single Dose Administration of 2 Doses of Imeglimin on QT/QTc Intervals in Healthy Subjects

The purpose of this study is to assess the effect of a single therapeutic dose and a single supra-therapeutic dose of imeglimin on the QT/QTc interval

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Hammersmith Medicines Research (HMR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteers
  • BMI between 18.5 and 29.9 kg/m2
  • weighing between 55 and 95 kg
  • 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 highly effective contraception
  • clinically relevant abnormal medical history, surgery or concurrent medical condition; acute or chronic illness
  • clinically significant QT/QTc interval prolongation at Baseline
  • history of drug-induced or risk factors for Torsade de Pointes
  • any contraindication to moxifloxacin
  • severe adverse reaction to any drug or sensitivity to the trial medication or its components
  • significant food allergy; use of vitamins, herbal medicines, prescription or over-the-counter medication (with the exception of paracetamol [acetaminophen] and oral contraceptives for women) within 20 days or 6 half-lives 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, 1 cigars or 1 pipes daily
  • regular consumption of more than 5 cups of caffeinated drinks per day
  • positive test for hepatitis A, B & C, HIV
  • objection by a General Practitioner.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imeglimin therapeutic dose
Tablet, oral, single dose
Drug: Imeglimin
Experimental: Imeglimin supratherapeutic dose
Tablet, oral, single dose
Drug: Imeglimin
Placebo Comparator: Placebo
Tablet, oral, single dose
Drug: Placebo
Active Comparator: Moxifloxacin
Tablet, oral, single dose (400 mg)
Drug: Moxifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in QTcF (deltaQTcF)
Time Frame: Up to 24 hours
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poxel SA

Investigators

  • Study Director: Julie Dubourg, MD, Poxel SA
  • Study Director: Pascale Fouqueray, MD, PhD, Poxel SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 4, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PXL008-016
  • 2016-001821-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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