Healthy
Conditions
Keywords
Healthy volunteer study
Brief summary
The purpose of this study is to evaluate the safety and tolerability of multiple ascending doses of ORM-12741.
Detailed description
The purpose is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple doses of ORM-12741 in healthy volunteers.
Interventions
DRUGORM-12741
Ascending multiple doses to sequential panels
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values | 12 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile (Cmax, tmax, t1/2, AUC, PTF) of ORM-12741 and its metabolites | PK samples will be collected for 12 days |
Countries
France
Outcome results
None listed