NCT00662883

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

3 months

First QC Date

April 16, 2008

Last Update Submit

April 21, 2008

Conditions

Healthy

Keywords

ketaminecorticosteroidintranasalphase IHealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters

    15 days

Study Arms (1)

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

Interventions

PMI-150 (intranasal ketamine HCl); mometasone furoateDRUG

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

Also known as: Nasonex
A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults
  • nonsmoker
  • no drug use

You may not qualify if:

  • nasal abnormalities
  • airway abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Mometasone Furoate

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Javelin Pharmaceuticals, Inc

    Javelin Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 21, 2008

Study Start

November 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

US(1)