Bioequivalence of Imeglimin Tablet Formulations

• Sponsor: Poxel SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03646331
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Days): 29
• Patients Per Site Per Month: 16.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Bioequivalence	Drug: Imeglimin Reference product; Drug: Imeglimin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 3, 2018
• Actual Primary Completion Date: Sep 27, 2018
• Actual Study Completion Date: Oct 2, 2018

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Pk parameters of imeglimin [from dosing up to 48h]

   Cmax: peak plasma concentration after dosing

Secondary Outcome Measures

1. PK parameters of Imeglimin [from dosing up to 48h]

   AUC last: area Under the concentration time curve

2. Incidence of treatment emergent adverse events (Safety and tolerability) [From Day 1 to Day 15]

   Incidence of treatment emergent adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

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

Sponsors and Collaborators

• Poxel SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poxel SA
• ClinicalTrials.gov Identifier: NCT03646331
• Other Study ID Numbers: PXL008-022
• First Posted: Aug 24, 2018
• Last Update Posted: Jan 11, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 11, 2019