Clinical trial NCT02724098: Bioavailability of Subcutaneous Dexmedetomidine
Official title: Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Palliative Therapy
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2016-03-31
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bioavailability (%) of subcutaneously given dexmedetomidine
timeFrame: 10 hours
Secondary outcomes:
measure: Change in hemodynamic parameter (blood pressure)
timeFrame: 10 hours
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 7 days
measure: Change in hemodynamic parameter (heart rate)
timeFrame: 10 hours
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital
Study officials:
affiliation: Dept. Anaesthesiology and Intensive Care, University Of Turku
name: Teijo I Saari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ashraf MW, Uusalo P, Scheinin M, Saari TI. Population Modelling of Dexmedetomidine Pharmacokinetics and Haemodynamic Effects After Intravenous and Subcutaneous Administration. Clin Pharmacokinet. 2020 Nov;59(11):1467-1482. doi: 10.1007/s40262-020-00900-3.
citation: Uusalo P, Al-Ramahi D, Tilli I, Aantaa RA, Scheinin M, Saari TI. Subcutaneously administered dexmedetomidine is efficiently absorbed and is associated with attenuated cardiovascular effects in healthy volunteers. Eur J Clin Pharmacol. 2018 Aug;74(8):1047-1054. doi: 10.1007/s00228-018-2461-1. Epub 2018 Apr 17.