NCT00847418

Brief Summary

The purpose of this study is the determination of blood concentration and the effectiveness of esketamine after nasal application.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 2, 2010

Status Verified

December 1, 2010

First QC Date

February 18, 2009

Last Update Submit

December 1, 2010

Conditions

Pain

Keywords

pharmacokineticsketamineAnesthetics, Dissociative

Study Arms (1)

Esketamine

EXPERIMENTAL
Drug: esketamine hydrochloride

Interventions

esketamine hydrochlorideDRUG
Esketamine

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • age ≥18 years ≤ 45 years
  • healthy
  • non-smoking
  • BMI 18-27

You may not qualify if:

  • abuse of drugs
  • known or supposed hypersensitivity and/or contraindication against ketamine or additives
  • participation of another clinical study within the last 30 days
  • chronic obstructed nose breathing or nasal polyps
  • dug allergy
  • blood donation within the last two months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manuel Haschke, MD

    Clinical Pharmacology and Toxicology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Study Completion

October 1, 2009

Last Updated

December 2, 2010

Record last verified: 2010-12

Locations

CH(1)