Safety and Pharmacokinetic Study With Multiple Ascending Doses of ORM-12741

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.

Detailed Description
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The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.

Official Title
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Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of ORM-12741

Conditions
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Healthy

Intervention / Treatment
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* Drug: ORM-12741
* Drug: Placebo for ORM-12741


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health ascertained by detailed medical history and physical examinations. Males between 18 and 45 years (inclusive). Body mass index (BMI) between 18-30 kg/m2 inclusive (BMI = weight/height2). Weight 55-100 kg (inclusive). Exclusion Criteria: Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator. Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study. Susceptibility to severe allergic reactions. Regular consumption of more than 14 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol). Current use of nicotine-containing products more than 5 cigarettes or equivalent/day. Inability to refrain from using nicotine-containing products during the stay at the study centre. Inability to refrain from consuming caffeine-containing beverages during the stay at the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages. Blood donation or loss of significant amount of blood within 3 months prior to the screening visit. Abnormal finding in ECG, vital signs, laboratory tests or physical examination. Intake of an investigational compound within 3 months prior to the start of this study or earlier participation in a clinical study with ORM-12741

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo for ORM-12741<br> | Drug: Placebo for ORM-12741<br> <br> |
| Experimental: ORM-12741<br> | Drug: ORM-12741<br>* Ascending multiple doses to sequential panels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values |  | 12 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer study