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

Sponsor:	Javelin Pharmaceuticals
Information provided by:	Javelin Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00662883

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 I

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Pharmacokinetics Study
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:

Drug Information available for: Mometasone furoate Ketamine hydrochloride Ketamine Corticosteroids

U.S. FDA Resources

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
A: Experimental 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

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

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

Keywords provided by Javelin Pharmaceuticals:

ketamine
corticosteroid
intranasal
phase I
Healthy volunteers

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Mometasone furoate
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anti-Allergic Agents

Anesthetics, Dissociative
Pharmacologic Actions
Sensory System Agents
Anesthetics, General
Therapeutic Uses
Ketamine
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 27, 2009