SedationPhase 1INDEXNCT00837187
Bioavailability of Dexmedetomidine After Intranasal Administration
A Phase 1 study testing Intravenous dexmedetomidine and Intranasal dexmedetomidine in people with Sedation, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sedation
- What is being tested?
- Intravenous dexmedetomidine and Intranasal dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2009to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)].
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects
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
- Being tested
- Intravenous dexmedetomidine, Intranasal dexmedetomidine
- Keywords
- dexmedetomidine, intranasal, pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous dexmedetomidineDrug
100 ug
Intranasal dexmedetomidineDrug
100 ug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous dexmedetomidine | Active comparator | Dexmedetomidine is administered intravenously Receives: Drug: Intravenous dexmedetomidine |
| Intranasal administration | Experimental | Dexmedetomidine is administered intranasally Receives: Drug: Intranasal dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The absolute bioavailability of intranasally administered dexmedetomidine
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SedationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Investigators
- Timo Iirola, MD, Principal investigator, Turku University HospitalKlaus T Olkkola, MD, PhD, Professor, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837187
- Sponsor's protocol ID
- INDEX
- Acronym
- INDEX
- Status last verified
- Jan 2009
- First submitted
- 4 Feb 2009
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21318594
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Dexmedetomidine After Intranasal Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00837187
- Acronym / sponsor ID
- INDEX / INDEX
- Conditions
- Sedation
- Keywords
- dexmedetomidine, intranasal, pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous dexmedetomidine | Active comparator | Drug: Intravenous dexmedetomidineDexmedetomidine is administered intravenously |
| Intranasal administration | Experimental | Drug: Intranasal dexmedetomidineDexmedetomidine is administered intranasally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous dexmedetomidine100 ug | Drug | Intravenous dexmedetomidine |
| Intranasal dexmedetomidine100 ug | Drug | Intranasal administration |
Primary outcome
The absolute bioavailability of intranasally administered dexmedetomidine
Time frame: At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h.
1 secondary outcome
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.
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Derived from this study: PubMed 21318594Iirola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Iirola, MD principal investigator
Turku University Hospital
Klaus T Olkkola, MD, PhD, Professor study director
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intravenous dexmedetomidine and Intranasal dexmedetomidine in people with Sedation, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The absolute bioavailability of intranasally administered dexmedetomidine (time frame: At baseline and 5, 10, 15, 20, 30, 45 min and 1, 1.5, 2, 3, 4, 5, 6, 8 and 10 h.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2010.