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

• Sponsor: Javelin Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00662883
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Feb 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameters [15 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy adults

• nonsmoker

• no drug use

Exclusion Criteria:

• nasal abnormalities

• airway abnormalities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Baltimore	Maryland	United States	21225

Sponsors and Collaborators

• Javelin Pharmaceuticals

Investigators

• Study Director: Javelin Pharmaceuticals, Inc, Javelin Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00662883
• Other Study ID Numbers: KET-PK-009
• First Posted: Apr 21, 2008
• Last Update Posted: Apr 22, 2008
• Last Verified: Apr 1, 2008

• Keywords provided by , ,: ketamine; corticosteroid; intranasal; phase I; Healthy volunteers
• Additional relevant MeSH terms: Mometasone Furoate; Ketamine

Study Results

No Results Posted as of Apr 22, 2008