Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00662883
First received: April 16, 2008
Last updated: April 21, 2008
Last verified: April 2008
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults
  • nonsmoker
  • no drug use

Exclusion Criteria:

  • nasal abnormalities
  • airway abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Javelin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00662883     History of Changes
Other Study ID Numbers: KET-PK-009
Study First Received: April 16, 2008
Last Updated: April 21, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ketamine
Mometasone furoate
Analgesics
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Anti-Allergic Agents
Anti-Inflammatory Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014