Multiple Dose Pharmacokinetics of Intranasal Ketamine
January 9, 2008 updated by: Javelin Pharmaceuticals
An Open Label, Single Center Study to Assess the Pharmacokinetics, Safety and Tolerability of Multiple Administrations of 30 mg PMI-150 (Intranasal Ketamine) in Healthy Adult Volunteers
This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.
Study Overview
Detailed Description
To examine safety and characterize the repeat dosing plasma profile, effect on absorption, and accumulation following repeated administration of 30 mg doses of PMI-150 (intranasal ketamine) to healthy adult volunteers.
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- under 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment A
intranasal ketamine
|
intranasal ketamine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pharmacokinetics
Time Frame: multiple
|
multiple
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Javelin Pharmaceuticals, Javelin Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
August 21, 2007
First Submitted That Met QC Criteria
August 21, 2007
First Posted (Estimate)
August 23, 2007
Study Record Updates
Last Update Posted (Estimate)
January 10, 2008
Last Update Submitted That Met QC Criteria
January 9, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- KET-PK-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.