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Completed

NCT Number: NCT02724098

Bioavailability of Subcutaneous Dexmedetomidine

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital

Turku, 20521, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

Primary outcomes

  1. Bioavailability (%) of subcutaneously given dexmedetomidine

    Time frame: 10 hours

    Noncompartmental analysis after non-linear mixed effects modelling.

Secondary outcomes

  1. Change in hemodynamic parameter (blood pressure)

    Time frame: 10 hours

    More than 30% change from the baseline in the blood pressure (measured in mmHg)

  2. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: 7 days

  3. 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)

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Official study title

Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers

Acronym: ScDex

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Sep 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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