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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00662883

Enrollment

Registered

2008-04-21

Start date

2007-11-30

Completion date

2008-02-29

Last updated

2008-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

ketamine, corticosteroid, intranasal, phase I, Healthy volunteers

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.

Interventions

DRUGPMI-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy adults * nonsmoker * no drug use

Exclusion criteria

* nasal abnormalities * airway abnormalities

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters	15 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026