Pain
Conditions
Keywords
Palliative Therapy
Brief summary
The aim of this study is to investigate the pharmacokinetics of subcutaneously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of subcutaneously administered dexmedetomidine will be calculated. In addition, the investigators will report the effects of subcutaneously administered dexmedetomidine on plasma catecholamine levels, vital signs such as systemic blood pressure, heart rate and sedation. The investigators will also monitor the local and systemic safety and tolerability of subcutaneously administered dexmedetomidine.
Interventions
DRUGDexmedetomidine
Sponsors
Turku University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Fluent skills in the Finnish language in order to be able to give informed consent and communicate with the study personnel. * Age ≥ 18 years. * Male gender. * Weight ≥ 60 kg. * Written informed consent from the subject.
Exclusion criteria
* Previous history of intolerance to the study drug or related compounds and additives. * Concomitant drug therapy of any kind except paracetamol in the 14 days prior to the study. * Existing or recent significant disease. * History of any kind of drug allergy. * Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements. * Donation of blood within six weeks prior to and during the study. * Body weight \< 60 kg or BMI \> 30 kg / m2. * Participation in any other clinical study involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study. * Smoking during one month before the start of the study or during the study period. * Clinically significant abnormal findings in physical examination, ECG or laboratory screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bioavailability (%) of subcutaneously given dexmedetomidine | 10 hours | Noncompartmental analysis after non-linear mixed effects modelling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemodynamic parameter (heart rate) | 10 hours | More than 30% change from the baseline in the blood pressure (measured in beats/minute) |
| Change in hemodynamic parameter (blood pressure) | 10 hours | More than 30% change from the baseline in the blood pressure (measured in mmHg) |
| Number of participants with adverse events as a measure of safety and tolerability | 7 days | — |
Countries
Finland
Outcome results
None listed