Bioavailability of Subcutaneous Dexmedetomidine

Study Overview
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Brief Summary
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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.

Official Title
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Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers

Conditions
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Pain

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous<br>1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) diluted in 10 ml of sodium chloride will be administered intravenously in 10 min at a constant rate using an infusion pump. | Drug: Dexmedetomidine<br> <br> |
| Active Comparator: subcutaneous<br>1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted. | Drug: Dexmedetomidine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability (%) of subcutaneously given dexmedetomidine | Noncompartmental analysis after non-linear mixed effects modelling. | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hemodynamic parameter (blood pressure) | More than 30% change from the baseline in the blood pressure (measured in mmHg) | 10 hours | 
| Number of participants with adverse events as a measure of safety and tolerability |  | 7 days | 
| Change in hemodynamic parameter (heart rate) | More than 30% change from the baseline in the blood pressure (measured in beats/minute) | 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Therapy