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The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.
The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo for ORM-12741 | Placebo Comparator |
| |
| ORM-12741 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORM-12741 | Drug | Ascending multiple doses to sequential panels |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites | PK samples will be collected for 12 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Déborah Metzger, MD | Forenap Pharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forenap Pharma | Rouffach | France |
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| ID | Term |
|---|---|
| C000588919 | ORM-12741 |
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| Placebo for ORM-12741 |
| Drug |
|