Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

Qt Interval, Variation in Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924337
• Other study ID #: PXL008-016
• Secondary ID: 2016-001821-14
• Status: Completed
• Phase: Phase 1
• First received: October 4, 2016
• Last updated: February 9, 2017
• Start date: September 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Qt Interval, Variation in

Intervention

Drug:
• Placebo

• Imeglimin

• Moxifloxacin

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research (HMR)	London

Sponsors (1)

Lead Sponsor	Collaborator
Poxel SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in QTcF (deltaQTcF)		Up to 24 hours