NCT00520169

Brief Summary

This is an open label, single-center study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_1 healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 10, 2008

Status Verified

January 1, 2008

Enrollment Period

2 months

First QC Date

August 21, 2007

Last Update Submit

January 9, 2008

Conditions

Healthy

Keywords

bioavailability

Outcome Measures

Primary Outcomes (1)

  • ketamine pharmacokinetics

    multiple

Study Arms (3)

A

ACTIVE COMPARATOR

oral ketamine

Drug: intranasal ketamine

B

EXPERIMENTAL

intranasal ketamine

Drug: intranasal ketamine

C

ACTIVE COMPARATOR

intravenous ketamine

Drug: intranasal ketamine

Interventions

intranasal ketamineDRUG

A randomized, open label, single center, single-dose study to determine the absolute bioavailability and nasopharyngeal absorption of PMI-150 (intranasal ketamine) 30mg in healthy adult volunteers. The Pilot Phase will be conducted as a parallel study, while the Test Phase will be conducted as a crossover study.

ABC

Eligibility Criteria

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

You may qualify if:

  • Healthy adults

You may not qualify if:

  • under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Javelin Pharmaceuticals

Cambridge, Massachusetts, 02140, United States

Location

Study Officials

  • Javelin Pharmaceuticals

    Javelin Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 21, 2007

First Posted

August 23, 2007

Study Start

July 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 10, 2008

Record last verified: 2008-01

Locations

US(1)