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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662883
First Posted: April 21, 2008
Last Update Posted: April 22, 2008
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.
Information provided by:
Javelin Pharmaceuticals
  Purpose
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Javelin Pharmaceuticals:

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

Enrollment: 18
Study Start Date: November 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Criteria

Inclusion Criteria:

  • healthy adults
  • nonsmoker
  • no drug use

Exclusion Criteria:

  • nasal abnormalities
  • airway abnormalities
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00662883


Locations
United States, Maryland
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Javelin Pharmaceuticals
Investigators
Study Director: Javelin Pharmaceuticals, Inc Javelin Pharmaceuticals
  More Information

Responsible Party: Javelin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00662883     History of Changes
Other Study ID Numbers: KET-PK-009
First Submitted: April 16, 2008
First Posted: April 21, 2008
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by Javelin Pharmaceuticals:
ketamine
corticosteroid
intranasal
phase I
Healthy volunteers

Additional relevant MeSH terms:
Ketamine
Mometasone Furoate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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