PharmacokineticsPhase 1NCT00520104
Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine
A Phase 1 study testing intranasal ketamine in people with Pharmacokinetics, run by Javelin Pharmaceuticals at 1 site in United States.
Trial summary
This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- intranasal ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Mar 2008
- 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
- Patients with Allergic Rhinitis
Who cannot join
- Under age 18
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 Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
This is an open label, single-center study to determine whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.
Read the detailed description
To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.
- Conditions
- Pharmacokinetics
- Being tested
- intranasal ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal ketamineDrug
drug interaction
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | intranasal ketamine Receives: Drug: intranasal ketamine |
| B | Experimental | oxymetazoline plus intranasal ketamine Receives: Drug: intranasal ketamine |
| C | Experimental | intranasal steroid plus intranasal ketamine Receives: Drug: intranasal ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 startAug 2007
- Primary completionFeb 2008
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
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
- NCT00520104
- Sponsor's protocol ID
- KET-PK-008
- Status last verified
- Aug 2007
- First submitted
- 21 Aug 2007
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Single Center, Single-Dose Study to Assess the Effects of Certain Nasal Medications on the Pharmacokinetics, Safety and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
- ClinicalTrials.gov ID
- NCT00520104
- Acronym / sponsor ID
- KET-PK-008
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Javelin PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (estimated)
- 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 whether certain nasal medication interact with PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers and in patients with allergic rhinitis.
Detailed description
To assess separately the effects of a nasal vasoconstrictor (oxymetazoline) and of a nasal steroid on the rate and extent of intranasal absorption of PMI-150 30 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: intranasal ketamineintranasal ketamine |
| B | Experimental | Drug: intranasal ketamineoxymetazoline plus intranasal ketamine |
| C | Experimental | Drug: intranasal ketamineintranasal steroid plus intranasal ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- Patients with Allergic Rhinitis
Key exclusion criteria (1 listed)
- Under age 18
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 ketaminedrug interaction | Drug | A, B, C |
Primary outcome
Pharmacokinetics
Time frame: multiple
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2008.
Related trials for Pharmacokinetics
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
Effects of Trigonelline Monohydrate on NAD+ Metabolism, Pharmacokinetics, Safety, and Tolerability in Healthy Adults
NAD+ Metabolism, Pharmacokinetics
Not yet recruitingObservational study
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
Healthy Volunteers, Safety
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 Pharmacokinetics, 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 2 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: status not confirmed, as of the sponsor's last update on 29 Feb 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?
Results are not available in the source record.
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?
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 29 Feb 2008; AzTrials last refreshed its copy on 8 Nov 2026.