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

Tracking Information

First Received Date ^ICMJE

April 16, 2008

Last Updated Date

April 21, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic parameters [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00662883 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Open Label, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate

Study Arms / Comparison Groups

Experimental:

PMI-150 (intranasal ketamine HCl), day 1
mometasone furoate, days 2-15
PMI-150 (intranasal ketamine HCl), day 15

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00662883

Responsible Party

Javelin Pharmaceuticals, Inc., Javelin Pharmaceuticals, Inc.

Study ID Numbers ^ICMJE

KET-PK-009

Study Sponsor ^ICMJE

Javelin Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Javelin Pharmaceuticals, Inc

Javelin Pharmaceuticals

Information Provided By

Javelin Pharmaceuticals

Verification Date

April 2008

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