Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to determine pharmacokinetic parameters of ORM-12741 in healthy volunteers.
Interventions
DRUGORM-12741
i.v., oral solution and oral capsule forms. Oral capsule given with and without food.
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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. * Finnish speaking males between 18 and 45 years of age (inclusive). * Body Mass Index (BMI) between 18-30 kg/m2 (inclusive, BMI = weight/height2). * Weight of 55-100 kg (inclusive).
Exclusion criteria
* A predictable poor compliance or inability to communicate well with the investigator. * Veins unsuitable for repeated venipuncture. * Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, 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 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 administration or less than 5 times a half-live 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 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 2 months prior to the screening visit. * Abnormal 12-lead ECG finding of clinical relevance after 10-minute rest in supine position 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. * HR \< 45 beats/minute or \> 100 beats/minute after 10-minute rest in supine position at the screening visit. * At the screening visit systolic blood pressure (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. * Any abnormal value of laboratory, vital signs, 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 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 study subject. * Participation in a clinical drug study within 3 months prior to the first study treatment administration of this study or earlier participation in a clinical study with ORM-12741.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic variables including: Peak concentration in plasma (Cmax), Time to peak concentration in plasma (tmax), Area under the plasma concentration-time curve (AUC) | 96 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). | throughout the study |
Countries
Finland
Outcome results
None listed