Bioavailability of Subcutaneous Dexmedetomidine

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT02724098
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-31
• Study Start: 2016-04
• Primary Completion: 2016-05
• Study Completion: 2017-05
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-11
• Last Update Posted: 2017-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
intravenous	Dexmedetomidine	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.
subcutaneous	Dexmedetomidine	1 µg/kg dexmedetomidine (dexmedetomidine hydrochloride 100 microg/ml, Dexdor® Orion Oyj, Espoo, Finland) will be administered subcutaneously undiluted.

Primary Outcome Measures

Name	Time	Method
Bioavailability (%) of subcutaneously given dexmedetomidine	10 hours	Noncompartmental analysis after non-linear mixed effects modelling.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital; 🇫🇮 Turku, Finland