Effect of Cimetidine on the PK of Imeglimin
- Registration Number
- NCT03618316
- Lead Sponsor
- Poxel SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-label imeglimin + cimetidine Imeglimin 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 Open-label imeglimin + cimetidine Cimetidine 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
- Primary Outcome Measures
Name Time Method PK parameters of imeglimin At Day 1 Cmax: peak plasma concentration after dosing
- Secondary Outcome Measures
Name Time Method PK parameters of imeglimin From day 1 to day 3 AUC last:area under the concentration-time curve
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] from day 1 to day 17 Incidence of Treatment-Emergent Adverse Events
Trial Locations
- Locations (1)
Hammersmith Medicines Research (HMR)
🇬🇧London, United Kingdom