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

April 21, 2008 updated by: Javelin Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adults
  • nonsmoker
  • no drug use

Exclusion Criteria:

  • nasal abnormalities
  • airway abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Nasonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters
Time Frame: 15 days
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javelin Pharmaceuticals

Investigators

  • Study Director: Javelin Pharmaceuticals, Inc, Javelin Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 21, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KET-PK-009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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