HealthyPhase 1NCT00520169
Absolute Bioavailability and Nasopharyngeal Absorption of Intranasal Ketamine
A Phase 1 study testing intranasal ketamine in people with Healthy, run by Javelin Pharmaceuticals at 1 site in United States.
Trial summary
This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- intranasal ketamine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2007
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- under 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Javelin Pharmaceuticals
Cambridge, Massachusetts, 02140
About this study
Official title: A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers
This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.
Read the detailed description
To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.
- Conditions
- Healthy
- Being tested
- intranasal ketamine
- Keywords
- bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal ketamineDrug
A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | oral ketamine Receives: Drug: intranasal ketamine |
| B | Experimental | intranasal ketamine Receives: Drug: intranasal ketamine |
| C | Active comparator | intravenous ketamine Receives: Drug: intranasal ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ketamine pharmacokinetics
Measured: multiple
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Javelin Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Javelin Pharmaceuticals, Study director, Javelin Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520169
- Sponsor's protocol ID
- KET-PK-007
- Status last verified
- Jan 2008
- First submitted
- 21 Aug 2007
- Last updated
- 10 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Center, Single-Dose, Cross-Over Study to Determine the Absolute Bioavailability and the Nasopharyngeal Absorption of PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00520169
- Acronym / sponsor ID
- KET-PK-007
- Conditions
- Healthy
- Keywords
- bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 23 Aug 2007 (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.
This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.
Detailed description
To examine the safety and assess the absolute bioavailability and nasopharyngeal absorption of PMI-150 30mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: intranasal ketamineoral ketamine |
| B | Experimental | Drug: intranasal ketamineintranasal ketamine |
| C | Active comparator | Drug: intranasal ketamineintravenous ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (1 listed)
- under 18 years
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 |
|---|---|---|
| intranasal ketamineA randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study. | Drug | A, B, C |
Primary outcome
ketamine pharmacokinetics
Time frame: multiple
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 10 Jan 2008.
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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.
Javelin Pharmaceuticals study director
Javelin Pharmaceuticals
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 intranasal ketamine in people with Healthy, run by Javelin Pharmaceuticals at 1 site in United States.
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 1 inclusion and 1 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 10 Jan 2008. 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 United States. 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?
ketamine pharmacokinetics (time frame: multiple). It is what the study was designed to measure, not a finding.
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 10 Jan 2008.