Effect of Cimetidine on the PK of Imeglimin

Study Overview
=================
Brief Summary
-----------------
The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.

Official Title
-----------------
An Open-label, One-sequence Study to Assess the Effect of Repeated Oral Doses of Cimetidine on the Single Dose Pharmacokinetics, Safety and Tolerability of Imeglimin in Healthy Caucasian Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Imeglimin
* Drug: Cimetidine


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Pregnant or lactating woman, or sexually active woman of child-bearing potential not using reliable contraception Clinically relevant abnormal findings at the screening assessment Clinically significant vital signs outside the acceptable range at screening Clinically relevant abnormal medical history, surgery or concurrent medical condition Acute or chronic illness Estimated glomerular filtration rate less than 80 mL/min/1.73 m2 Severe adverse reaction to any drug or sensitivity to the trial medication or its components Significant food allergy; vegetarian or vegan 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 daily Possibility that subject will not cooperate Positive test for hepatitis B & C, HIV Objection by a General Practitioner

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label imeglimin + cimetidine<br>Day 1: single oral dose of 1,500 mg imeglimin Day 5 to Day 10 inclusive: repeated doses of 400 mg cimetidine twice daily Day 8: second 1,500 mg dose of imeglimin together with the morning dose of cimetidine | Drug: Imeglimin<br>* 2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8)<br>Drug: Cimetidine<br>* 400 mg of cimetidine bid from Day 5 to Day 10<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of imeglimin | Cmax: peak plasma concentration after dosing | At Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of imeglimin | AUC last:area under the concentration-time curve | From day 1 to day 3 | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events | from day 1 to day 17 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, Drug-drug interaction