NOCIFIM: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ODM-104 when given to healthy male volunteers.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ODM-104 Oral capsules dosage 10-800mg once daily for one day or three times daily for 7 days |
Drug: ODM-104
ODM-104
|
Placebo Comparator: Placebo Oral capsules given once daily for one day or three times daily for 7 days |
Drug: Placebo
Placebo
|
Active Comparator: entacapone + levodopa/carbidopa entacapone: oral tablet 200mg given four times daily for one day; levodopa/carbidopa: oral tablet 100/25mg given four times daily for one day |
Drug: Entacapone
entacapone + levodopa/carbidopa
Drug: levodopa/carbidopa
entacapone + levodopa/carbidopa
|
Outcome Measures
Primary Outcome Measures
- Erythrocyte Catechol-O-methyltransferase (COMT) inhibition. [0, 0.16, 0.33, 0.5, 0.75,1.0,1.5, 2, 3, 4, 6, 10, 16, 24h post dose]
Maximal COMT inhibition and area under the COMT inhibition curve (AUCC)
Secondary Outcome Measures
- Area under the plasma concentration curve (AUC) [0, 0.16, 0.33, 0.5, 0.75, 1, 1.5, 2, 2, 4, 6, 10, 16, 24h post dose]
AUC under the plasma concentration curve
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male subjects aged between 18 and 45 years
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BMI 18-30 kg/m2
-
Weight 55-95kg
-
Written informed consent
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Good General Health
Exclusion Criteria:
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Vulnerable subjects
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Veins unsuitable for repeated venipuncture
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Evidence of clinically significant cardiovascular, renal, hepatic, hematological, Gi, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disorder
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History of or positive test for drug abuse
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Any condition requiring regular concomitant medication
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Blood donation or significant loss of blood within 2 months prior to screening
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Abnormal 12 lead ECG finding of clinical relevance
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Heart rate (HR) <50bpm or >90bpm after 10 minutes in a supine position
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Systolic blood pressure <90mmHg or >140mmHg after 10 minutes in a supine position
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Diastolic blood pressure <50mmHg or >90mmHg after 10 minutes in a supine position
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Abnormal 24 hour Holter recording of clinical relevance at screening
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Any abnormal laboratory value, vital signs or physical examination causing a health risk to the volunteer
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Parexel International GmbH | Berlin | Germany |
Sponsors and Collaborators
- Orion Corporation, Orion Pharma
Investigators
- Principal Investigator: Rainard Fuhr, MD, Parexel
- Study Director: angela ruck, PhD, Orion Corporation, Orion Pharma
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3112001