Healthy
Conditions
Keywords
Healthy volunteers
Brief summary
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 and ORM-14540 in healthy volunteers.
Interventions
DRUGORM-14540
i.v.
DRUGORM-12741
i.v.
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent (IC) obtained. * 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
* A predictable poor compliance or inability to communicate well with the investigator or study centre personnel. * Veins unsuitable for repeated venipuncture * Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric diseases as judged by the investigator. * Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant 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 treatment or less than 5 times a half-life of the medication. Possible enzyme inducing drugs will be discussed case-by-case with the sponsor. * 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 at the study centre. * Inability to refrain from consuming caffeine-containing beverages during the stay in 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 2 months prior to the screening visit. * Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance in supine position after resting for 10 minutes at the screening visit, for example:- QTc (calculated through the Bazett's formula) \> 450msec,- PR \< 120 msec or \> 210 msec,- QRS \< 70 msec or \> 120 msec. * Heart rate (HR) \< 45 beats/minute or \> 100 beats/minute in supine position after resting for 10 minutes at the screening visit. * At the screening visit, systolic blood pressure (BP) \< 90 mmHg or \> 140 mmHg in supine position after resting for 10 minutes, diastolic BP \< 50 mmHg or \> 90 mmHg in supine position after resting for 10 minutes. * Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study. * History of drug abuse or positive result in drug abuse test. * Positive serology to human immunodeficiency virus antigen/antibodies (HIVAgAb), hepatitis C virus antibodies (HCVAb) or hepatitis B surface antigen (HBsAg). * 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. * Participation in a clinical drug study within 3 months prior to the screening visit in this study, or earlier participation in a clinical study with ORM-12741. * Exposure to 14C-labelled drugs or diagnostics within 12 months prior to the screening visit. * Men who are not practising clinically accepted method of contraception during the study and next 3 months after the study treatment administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables including: Area under the concentration-time curve (AUC), Maximum observed concentration (Cmax) at the end of infusion, Terminal elimination half-life (t½z), Total clearance (CL) | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables including blood pressure (BP), heart rate (HR), electrocardiograms (ECGs), physical examination, laboratory safety variables (haematology, chemistry, serology and urinalysis) and adverse events (AEs). | Before and after study |
Countries
Finland
Outcome results
None listed