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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label imeglimin + cimetidine | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imeglimin | Drug | 2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of imeglimin | Cmax: peak plasma concentration after dosing | At Day 1 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Caucasian
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research (HMR) | London | United Kingdom |
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| ID | Term |
|---|---|
| C575881 | imeglimin |
| D002927 | Cimetidine |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 |
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| Cimetidine | Drug | 400 mg of cimetidine bid from Day 5 to Day 10 |
|
| from day 1 to day 17 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |