Bioequivalence of Imeglimin Tablet Formulations

A Phase I, Open-label, Randomised, Single-centre, 2-way Crossover Bioequivalence Study Comparing 2 Formulations of Imeglimin After Single Oral Doses in Healthy Caucasian Subjects

This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A [reference product] and Tablet B [test product]), in at least 16 healthy Caucasian volunteers.

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: Imeglimin Reference product; Drug: Imeglimin

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• BMI : 18.5-29.9
• Body weight ≥ 60 kg
• willing to use reliable contraception
• able to give fully informed written consent.

Exclusion Criteria:

• Positive tests for hepatitis B & C, HIV
• severe adverse reaction to any drug; sensitivity to trial medication and/or food allergies
• drug or alcohol abuse
• smoking of more than 5 cigarettes daily or drinking more than 5 cups of caffeinated drinks daily
• over-the-counter medication, vitamins and herbal remedies, or prescribed medication in the 20 days before the first dose of trial medication (with the exception of paracetamol [acetaminophen] and oral contraception);
• participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months
• vital signs outside the acceptable range
• clinically relevant abnormal findings at the screening assessment; estimated glomerular filtration rate (eGFR) at screening < 80 mL/min/1.73 m2
• acute or chronic illness
• clinically relevant abnormal medical history or concurrent medical condition;
• surgery or medical condition that might affect the absorption of medicines;
• possibility that volunteer will not cooperate
• pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception;
• objection by the volunteer's General Practitioner (GP).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tablet A in Session 1 and Tablet B in Session 2; Tablet A = reference product Tablet B = test product	Drug: Imeglimin Reference product; Reference product; Drug: Imeglimin; Test product (new formulation tablet)
Experimental: Tablet B in Session 1 and Tablet A in Session 2; Tablet A = reference product Tablet B = test product	Drug: Imeglimin Reference product; Reference product; Drug: Imeglimin; Test product (new formulation tablet)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pk parameters of imeglimin	Cmax: peak plasma concentration after dosing	from dosing up to 48h

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of Imeglimin	AUC last: area Under the concentration time curve	from dosing up to 48h
Incidence of treatment emergent adverse events (Safety and tolerability)	Incidence of treatment emergent adverse events	From Day 1 to Day 15

Collaborators and Investigators

• Sponsor: Poxel SA

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2018
• Primary Completion (Actual): September 27, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PXL008-022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No