Status:
COMPLETED
Safety and Tolerability Study With Single Ascending Doses of ODM-102
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of escalating single doses of ODM-102 in healthy volunteers
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01839019
Start Date
April 1 2013
End Date
August 1 2013
Last Update
February 10 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Services Turku, CRST
Turku, Finland, 20520