Effect of Imeglimin on QT/QTc Intervals in Healthy Subjects

• Sponsor: Poxel SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02924337
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 18.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Qt Interval, Variation in	Drug: Placebo; Drug: Imeglimin; Drug: Moxifloxacin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change from baseline in QTcF (deltaQTcF) [Up to 24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammersmith Medicines Research (HMR)	London		United Kingdom

Sponsors and Collaborators

• Poxel SA

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poxel SA
• ClinicalTrials.gov Identifier: NCT02924337
• Other Study ID Numbers: PXL008-016; 2016-001821-14
• First Posted: Oct 5, 2016
• Last Update Posted: Feb 10, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Poxel SA: QT/QTC interval; Hypoglycemic Agents; Imeglimin; Healthy Volunteers
• Additional relevant MeSH terms: Moxifloxacin

Study Results

No Results Posted as of Feb 10, 2017