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The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ORM-12741 i.v. | Experimental |
| |
| ORM-12741 oral solution | Experimental |
| |
| ORM-12741 oral capsule with food | Experimental |
| |
| ORM-12741 oral capsule without food | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORM-12741 | Drug | i.v., oral solution and oral capsule forms. Oral capsule given with and without food. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC) | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs). | throughout the study |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juha Peltonen, MD | CRST | Principal Investigator |
| Virpi Mononen | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRST | Turku | Finland |
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| ID | Term |
|---|---|
| C000588919 | ORM-12741 |
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