NCT02724098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4 pain

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 12, 2017

Status Verified

September 1, 2017

Enrollment Period

1 month

First QC Date

February 12, 2016

Last Update Submit

September 11, 2017

Conditions

Pain

Keywords

Palliative Therapy

Outcome Measures

Primary Outcomes (1)

  • Bioavailability (%) of subcutaneously given dexmedetomidine

    Noncompartmental analysis after non-linear mixed effects modelling.

    10 hours

Secondary Outcomes (3)

  • Change in hemodynamic parameter (blood pressure)

    10 hours

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

    7 days

  • Change in hemodynamic parameter (heart rate)

    10 hours

Study Arms (2)

intravenous

ACTIVE COMPARATOR

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

subcutaneous

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG
intravenoussubcutaneous

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Turku, 20521, Finland

Location

Related Publications (2)

  • 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.

    PMID: 32462542DERIVED

  • 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.

    PMID: 29666901DERIVED

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Teijo I Saari, MD, PhD

    Dept. Anaesthesiology and Intensive Care, University Of Turku

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2016

First Posted

March 31, 2016

Study Start

April 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2017

Last Updated

September 12, 2017

Record last verified: 2017-09

Locations

FI(1)