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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate

• Registration Number: NCT00662883
• Lead Sponsor: Javelin Pharmaceuticals

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2008-04
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-21
• Last Update Submitted: 2008-04-21
• Last Update Posted: 2008-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• healthy adults
• nonsmoker
• no drug use

Exclusion Criteria

• nasal abnormalities
• airway abnormalities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	PMI-150 (intranasal ketamine HCl); mometasone furoate	* PMI-150 (intranasal ketamine HCl), day 1 * mometasone furoate, days 2-15 * PMI-150 (intranasal ketamine HCl), day 15

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters	15 days