Bioequivalence of Imeglimin Tablet Formulations

NCT03646331 | Completed Phase 1

• 1 other identifier: PXL008-022
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

• Pk parameters of imeglimin

  Cmax: peak plasma concentration after dosing

  from dosing up to 48h

Secondary Outcomes (2)

• PK parameters of Imeglimin

  from dosing up to 48h

• Incidence of treatment emergent adverse events (Safety and tolerability)

  From Day 1 to Day 15

Study Arms (2)

Tablet A in Session 1 and Tablet B in Session 2

EXPERIMENTAL

Tablet A = reference product Tablet B = test product

Drug: Imeglimin Reference product; Drug: Imeglimin

Tablet B in Session 1 and Tablet A in Session 2

EXPERIMENTAL

Tablet A = reference product Tablet B = test product

Drug: Imeglimin Reference product; Drug: Imeglimin

Interventions

Imeglimin Reference product DRUG

Reference product

Tablet A in Session 1 and Tablet B in Session 2; Tablet B in Session 1 and Tablet A in Session 2

Imeglimin DRUG

Test product (new formulation tablet)

Tablet A in Session 1 and Tablet B in Session 2; Tablet B in Session 1 and Tablet A in Session 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Poxel SA: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, United Kingdom

Location

MeSH Terms

Interventions

imeglimin

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: September 3, 2018
• Primary Completion: September 27, 2018
• Study Completion: October 2, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

GB (1)