Healthy Volunteers
Conditions
Keywords
Healthy volunteers
Brief summary
The purpose of the study is to evaluate the safety and tolerability of escalating single doses of ODM-102 in healthy volunteers
Interventions
DRUGODM-102
Single dose escalation
DRUGPlacebo for ODM-102
Single dose escalation
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
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measures, i.e. assessing adverse events, vital signs, ECG and safety laboratory values | about a month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 5 days per period | Explore the PK profile (e.g. Cmax, tmax, AUC, t1/2), screen circulating metabolites and determine protein binding. |
Countries
Finland
Outcome results
None listed