Pharmacokinetics and Pharmacodynamics of Nasally Applied... | NCT00847418

Studies
Pharmacokinetics and Pharmacodynamics of Nasally Applied Esketamine

NCT00847418

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Dec 2, 2010Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Pain

Interventions

esketamine hydrochloride

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Not provided

Completion Date

Oct 2009Actual

First Submitted Date

Feb 18, 2009

First Submission Date that Met QC Criteria

Feb 18, 2009

First Posted Date

Feb 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2010

Last Update Posted Date

Dec 2, 2010Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
Esketamine	Experimental		Drug: esketamine hydrochloride

Name	Type	Description	Arm Group Labels	Other Names
esketamine hydrochloride	Drug		Esketamine

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel Haschke, MD	Clinical Pharmacology and Toxicology, University Hospital Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Center, University Hospital Basel		Basel	Canton of Basel-City	4031	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided