Bioavailability of Subcutaneous Dexmedetomidine (ScDex)

September 11, 2017 updated by: Turku University Hospital

Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioavailability (%) of subcutaneously given dexmedetomidine
Time Frame: 10 hours
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)
Time Frame: 10 hours
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
Time Frame: 7 days
7 days
Change in hemodynamic parameter (heart rate)
Time Frame: 10 hours
More than 30% change from the baseline in the blood pressure (measured in beats/minute)
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

February 12, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (ESTIMATE)

March 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 11, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T30/2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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