Bioavailability of Dexmedetomidine After Intranasal Administration

NCT00837187 | Completed Phase 1

• 1 other identifier: INDEX
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

In a recent study by Yuen et al it was shown that preoperative intranasal administration of dexmedetomidine is a useful alternative for oral midazolam in children. However, there is no information on the pharmacokinetics of dexmedetomidine after intranasal administration. The aim of this study is to investigate the comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers. The absolute bioavailability of intranasally administered dexmedetomidine will be calculated. In addition, we will report the effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation. We will also monitor the local and systemic safety and tolerability of intranasally administered dexmedetomidine.

Conditions

Sedation

Keywords

dexmedetomidine; intranasal; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• The absolute bioavailability of intranasally administered dexmedetomidine

  At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h.

Secondary Outcomes (1)

• The effects of intranasally and intravenously administered dexmedetomidine on plasma catecholamine levels, systemic blood pressure, heart rate and sedation, local and systemic safety and tolerability of intranasal dexmedetomidine.

  At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 5 and 10 h. Only local nasal tolerability is assessed at 5 and 10 h.

Study Arms (2)

Intravenous dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine is administered intravenously

Drug: Intravenous dexmedetomidine

Intranasal administration

EXPERIMENTAL

Dexmedetomidine is administered intranasally

Drug: Intranasal dexmedetomidine

Interventions

Intravenous dexmedetomidine DRUG

100 ug

Intravenous dexmedetomidine

Intranasal dexmedetomidine DRUG

100 ug

Intranasal administration

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (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 hematological, endocrine, metabolic or gastrointestinal disease.
• History of asthma or 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.
• Special diet or lifestyle factors which would compromise the conditions of the study or the interpretation of the results.
• 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 \[routine haematology (haemoglobin, haematocrit, red blood cell count, white blood cell count, platelets), renal function tests (creatinine, urea) and liver function tests (bilirubin)\].

Sponsors & Collaborators

• University of Turku: lead

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

Location

Related Publications (1)

• Iirola T, Vilo S, Manner T, Aantaa R, Lahtinen M, Scheinin M, Olkkola KT. Bioavailability of dexmedetomidine after intranasal administration. Eur J Clin Pharmacol. 2011 Aug;67(8):825-31. doi: 10.1007/s00228-011-1002-y. Epub 2011 Feb 12.

  PMID: 21318594 DERIVED

Study Officials

• Timo Iirola, MD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

• Klaus T Olkkola, MD, PhD, Professor

  Turku University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 13, 2010

Record last verified: 2009-01

Locations

FI (1)