NCT00519987

Brief Summary

This is an open label, single-center study of the pharmacokinetic and safety profile of repeat doses of PMI-150 (intranasal ketamine) 30 mg in healthy adult volunteers.

Trial Health

100
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 Jun 2007

Shorter than P25 for phase_1 healthy

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

June 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
20 days 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
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

pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics

    multiple

Study Arms (1)

Treatment A

EXPERIMENTAL

intranasal ketamine

Drug: intranasal ketamine

Interventions

intranasal ketamineDRUG

intranasal ketamine

Treatment A

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 Officials

  • Javelin Pharmaceuticals

    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

August 21, 2007

First Posted

August 23, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

January 10, 2008

Record last verified: 2008-01