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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-002718-11 | EudraCT Number |
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An open label, multicentre, randomised, 2-cohort, sequential and crossover study to assess the relative oral bioavailability of MT-7117 higher content tablets versus MT-7117 lower content tablets and the pharmacokinetics of MT-7117 under various gastric conditions (fed and fasted, and following administration of a proton pump inhibitor and an acidic beverage) in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-7117 BA and DDI (fasted) | Experimental | MT-7117 lower content tablets, higher content tablets, higher content tablets with PPI (fasted), higher content tablets with PPI and acidic beverage (fasted) |
|
| MT-7117 food effect and DDI (fed) | Experimental | MT-7117 higher content tablets (fasted and fed), higher content tablets with PPI (fed), higher content tablets with PPI and acidic beverage (fed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-7117 | Drug | MT-7117 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Pre-dose and up to 48 hours following each single dose | |
| Area under the plasma concentration time curve from time zero to last quantifiable concentration (AUC0-t) | Pre-dose and up to 48 hours following each single dose | |
| Area under the plasma concentration time curve from time zero to infinity (AUC0-inf) | Pre-dose and up to 48 hours following each single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious AEs | up to 48 hours post dose |
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Inclusion Criteria:
Additional screening criteria check may apply for qualification:
Exclusion Criteria:
Additional screening criteria check may apply for qualification:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Mitsubishi Tanabe Pharma Europe Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Centre(s) | Germany | Germany |
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Open Label
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| PPI |
| Drug |
Proton pump inhibitor |
|
| Acidic beverage | Dietary Supplement | Acidic beverage |
|