PainPhase 1NCT00847418
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
A Phase 1 study testing esketamine hydrochloride in people with Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- esketamine hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Oct 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- age ≥18 years ≤ 45 years
- healthy
- non-smoking
- BMI 18-27
Who cannot join
- abuse of drugs
- known or supposed hypersensitivity and/or contraindication against ketamine or additives
- participation of another clinical study within the last 30 days
- chronic obstructed nose breathing or nasal polyps
- dug allergy
- blood donation within the last two months
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Research Center, University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.
- Conditions
- Pain
- Being tested
- esketamine hydrochloride
- Keywords
- pharmacokinetics, ketamine, Anesthetics, Dissociative
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esketamine hydrochlorideDrug
| Study group | Role | What they receive |
|---|---|---|
| Esketamine | Experimental | Not described Receives: Drug: esketamine hydrochloride |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Manuel Haschke, MD, Principal investigator, Clinical Pharmacology and Toxicology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847418
- Sponsor's protocol ID
- EKBB 351/08, 2009DR1015
- Status last verified
- Dec 2010
- First submitted
- 18 Feb 2009
- Last updated
- 2 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine
- ClinicalTrials.gov ID
- NCT00847418
- Acronym / sponsor ID
- EKBB 351/08, 2009DR1015
- Conditions
- Pain
- Keywords
- pharmacokinetics, ketamine, Anesthetics, Dissociative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Feb 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 19 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.
The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esketamine | Experimental | Drug: esketamine hydrochloride |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male
- age ≥18 years ≤ 45 years
- healthy
- non-smoking
- BMI 18-27
Key exclusion criteria (6 listed)
- abuse of drugs
- known or supposed hypersensitivity and/or contraindication against ketamine or additives
- participation of another clinical study within the last 30 days
- chronic obstructed nose breathing or nasal polyps
- dug 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 |
|---|---|---|
| esketamine hydrochloride | Drug | Esketamine |
Primary outcome
Not reported in the source record.
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 2 Dec 2010.
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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.
Manuel Haschke, MD principal investigator
Clinical Pharmacology and Toxicology, University Hospital Basel
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 esketamine hydrochloride in people with Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 6 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 2 Dec 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 Switzerland. 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.
Where can I read the original study information?
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 2 Dec 2010.