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Determination of Drug Interactions of Certain Nasal Medications With Intranasal Ketamine

This study is ongoing, but not recruiting participants.
Information provided by:
Javelin Pharmaceuticals Identifier:
First received: August 21, 2007
Last updated: February 27, 2008
Last verified: August 2007
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.

Condition Intervention Phase
Drug: intranasal ketamine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Javelin Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: multiple ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2007
Estimated Study Completion Date: March 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
intranasal ketamine
Drug: intranasal ketamine
drug interaction
Experimental: B
oxymetazoline plus intranasal ketamine
Drug: intranasal ketamine
drug interaction
Experimental: C
intranasal steroid plus intranasal ketamine
Drug: intranasal ketamine
drug interaction

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adults
  • Patients with Allergic Rhinitis

Exclusion Criteria:

  • Under age 18
  Contacts and Locations
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Please refer to this study by its identifier: NCT00520104

United States, Massachusetts
Javelin Pharmaceuticals
Cambridge, Massachusetts, United States, 02140
Sponsors and Collaborators
Javelin Pharmaceuticals
Study Director: Javelin Pharmaceuticals Javelin Pharmaceuticals
  More Information

Responsible Party: Javelin Pharmaceuticals Identifier: NCT00520104     History of Changes
Other Study ID Numbers: KET-PK-008 
Study First Received: August 21, 2007
Last Updated: February 27, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on January 17, 2017