Healthy Volunteers Clinical Trial
Official title:
Safety, Tolerability and Pharmacokinetics of Single Escalating Doses of ODM-102: A Randomised, Double-blind, Placebo-controlled, Single Centre Study in Healthy Males
The purpose of the study is to evaluate the safety and tolerability of escalating single doses of ODM-102 in healthy volunteers
Status | Completed |
Enrollment | 22 |
Est. completion date | August 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Finland | Clinical Research Services Turku, CRST | Turku |
Lead Sponsor | Collaborator |
---|---|
Orion Corporation, Orion Pharma |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values | about a month | Yes | |
Secondary | Pharmacokinetics | Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2), screen circulating metabolites and determine protein binding. | 5 days per period | No |
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