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Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00662883
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : April 22, 2008
Information provided by:
Javelin Pharmaceuticals

Brief Summary:
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Condition or disease Intervention/treatment Phase
Healthy Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate Phase 1

Detailed Description:
Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Randomized, Open Label Study to Assess the Effects of a Nasal Corticosteroid on the Pharmacokinetics, Safety, and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg
Study Start Date : November 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
  • PMI-150 (intranasal ketamine HCl), day 1
  • mometasone furoate, days 2-15
  • PMI-150 (intranasal ketamine HCl), day 15
Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate
  • 1 dose PMI-150 (intranasal ketamine HCl); day 1
  • mometasone furoate, daily; days 2-15
  • 1 dose PMI-150 (intranasal ketamine HCl); day 15
Other Name: Nasonex

Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy adults
  • nonsmoker
  • no drug use

Exclusion Criteria:

  • nasal abnormalities
  • airway abnormalities

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00662883

United States, Maryland
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Javelin Pharmaceuticals
Study Director: Javelin Pharmaceuticals, Inc Javelin Pharmaceuticals

Responsible Party: Javelin Pharmaceuticals, Inc. Identifier: NCT00662883     History of Changes
Other Study ID Numbers: KET-PK-009
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by Javelin Pharmaceuticals:
phase I
Healthy volunteers

Additional relevant MeSH terms:
Mometasone Furoate
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
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents