Status:
COMPLETED
Safety and Tolerability Study With Single Ascending Doses of ORM-12741
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of escalating doses of ORM-12741 in healthy volunteers.
Eligibility Criteria
Inclusion
- Good general health ascertained by detailed medical history and physical examinations
- Males between 18 and 45 years
- Body mass index (BMI) between 18-30 kg/m2
- Weight 55-90 kg
Exclusion
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
- Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
- Susceptibility to severe allergic reactions
- Regular consumption of more than 14 units of alcohol per week
- 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 stay in the study centre
- 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
- Participation in a drug study within 3 months prior to the start of this study
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00693316
Start Date
July 1 2008
End Date
October 1 2009
Last Update
February 11 2010
Active Locations (1)
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1
Forenap Pharma
Rouffach, France, 68250