Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00662883
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
Javelin Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 16, 2008
First Posted Date  ICMJE April 21, 2008
Last Update Posted Date April 22, 2008
Study Start Date  ICMJE November 2007
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2008)
Pharmacokinetic parameters [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)
Official Title  ICMJE 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
Brief Summary To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: A
  • PMI-150 (intranasal ketamine HCl), day 1
  • mometasone furoate, days 2-15
  • PMI-150 (intranasal ketamine HCl), day 15
Intervention: Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2008)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2008
Actual Primary Completion Date February 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy adults
  • nonsmoker
  • no drug use

Exclusion Criteria:

  • nasal abnormalities
  • airway abnormalities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00662883
Other Study ID Numbers  ICMJE KET-PK-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Javelin Pharmaceuticals, Inc.
Study Sponsor  ICMJE Javelin Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Javelin Pharmaceuticals, Inc Javelin Pharmaceuticals
PRS Account Javelin Pharmaceuticals
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP