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The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.
The study is divided into two parts. Part one is a crossover study where healthy volunteers will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple ascending dose parallel group study where healthy volunteers will receive ODM-104 three times daily for seven days. Healthy volunteers taking part in Part II of the study will also receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODM-104 | Experimental | Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days |
|
| Placebo | Placebo Comparator | Oral capsules given once daily for one day or three times daily for 7 days |
|
| entacapone + levodopa/carbidopa | Active Comparator | entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODM-104 | Drug | ODM-104 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Erythrocyte Catechol-O-methyltransferase (COMT) inhibition. | Maximal COMT inhibition and area under the COMT inhibition curve (AUCC) | 0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration curve (AUC) | AUC under the plasma concentration curve | 0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainard Fuhr, MD | Parexel | Principal Investigator |
| angela ruck, PhD | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | Germany |
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| ID | Term |
|---|---|
| C071192 | entacapone |
| C009265 | carbidopa, levodopa drug combination |
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| Drug |
Placebo |
|
| Entacapone | Drug | entacapone + levodopa/carbidopa |
|
| levodopa/carbidopa | Drug | entacapone + levodopa/carbidopa |
|