Safety and Tolerability Study With Single Ascending Doses of ODM-102

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the safety and tolerability of escalating single doses of ODM-102 in healthy volunteers

Official Title
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Safety, Tolerability and Pharmacokinetics of Single Escalating Doses of ODM-102: A Randomised, Double-blind, Placebo-controlled, Single Centre Study in Healthy Males

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ODM-102
* Drug: Placebo for ODM-102


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent (IC) obtained. Good general health ascertained by detailed medical history and physical examination. Finnish-speaking males between 18 and 45 years of age (inclusive). Body mass index (BMI) between 18.0-30.5 kg/m2 (inclusive). Weight 55.0-100.0 kg (inclusive). Exclusion Criteria: Suspected poor compliance or inability to communicate well with the investigator. Veins unsuitable for repeated venipuncture. 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 drug treatment, including herbal products, or likely to need any concomitant drug treatment during the study. Susceptibility to severe allergic reactions. Intake of any medication that could affect the outcome of the study within 2 weeks prior to the first study drug administration or within less than 5 times the elimination half-life of the medication. Regular consumption of more than 21 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 in the study centre. Inability to refrain from consuming caffeine-containing beverages during the first 24 hours after treatment administration e.g. propensity to experience headache when abstaining from caffeine-containing beverages. Blood donation or loss of a significant amount of blood within 2 months prior to the screening visit. Abnormal 12-lead ECG finding of clinical relevance after 10 min rest in supine position at the screening visit HR < 45 beats/minute or > 90 beats/minute after 10 minutes rest in supine position at the screening visit. At the screening visit, systolic BP < 90 mmHg or > 140 mmHg after 10 minutes in supine position, diastolic BP < 50 mmHg or > 90 mmHg after 10 minutes in supine position, or symptomatic orthostatic hypotension, or decrease of ≥ 20 mmHg of systolic BP or decrease of ≥ 10 mmHg of diastolic BP after 3 minutes in standing position. Abnormal 24-hour Holter ECG recording of possible or confirmed clinical relevance Any abnormal laboratory value, vital sign, or physical examination finding, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk to the subject if he takes part in the study. Suspected current use of illicit drugs (according to medical history enquiry or physical examination), positive drug screen or history of long-term drug abuse. Positive serology to human immunodeficiency virus antigen/antibodies (HIVAgAb), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibodies (HCVAb). Participation in another clinical drug study within 3 months prior to the first treatment administration in this study. Any other condition that in the opinion of the investigator would interfere with the evaluation of the results or constitute a health risk for the subject.

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<br>Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo. | Drug: Placebo for ODM-102<br>* Single dose escalation<br>|
| Experimental: ODM-102<br>Each subject will receive 2 single doses of study drug, either both of them active doses or the other placebo. | Drug: ODM-102<br>* Single dose escalation<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 and safety laboratory values |  | about a month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2), screen circulating metabolites and determine protein binding. | 5 days per period | 

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