Bioavailability of Subcutaneous Dexmedetomidine

Pain Clinical Trial

— ScDex  

Official title:

Bioavailability of Subcutaneously Given Dexmedetomidine in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724098
• Other study ID #: T30/2016
• Status: Completed
• Phase: Phase 4
• First received: February 12, 2016
• Last updated: September 11, 2017
• Start date: April 2016
• Est. completion date: May 2017

Study information

• Verified date: September 2017
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Dexmedetomidine

Locations

Country	Name	City	State
Finland	Perioperative Services, Intensive Care and Pain Therapy, Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability (%) of subcutaneously given dexmedetomidine	Noncompartmental analysis after non-linear mixed effects modelling.	10 hours
Secondary	Change in hemodynamic parameter (blood pressure)	More than 30% change from the baseline in the blood pressure (measured in mmHg)	10 hours
Secondary	Number of participants with adverse events as a measure of safety and tolerability		7 days
Secondary	Change in hemodynamic parameter (heart rate)	More than 30% change from the baseline in the blood pressure (measured in beats/minute)	10 hours