A Study of ABT-384 Levels and Pharmacodynamic Activity Me... | NCT01009216

Studies
A Study of ABT-384 Levels and Pharmacodynamic Activity Measured in Cerebrospinal Fluid

NCT01009216

Sponsor

Abbott

Status

Completed

Last Update Posted

Dec 14, 2010Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

ABT-384

Countries

United States

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

Nov 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

Oct 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Oct 21, 2009

First Submission Date that Met QC Criteria

Nov 5, 2009

First Posted Date

Nov 6, 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 13, 2010

Last Update Posted Date

Dec 14, 2010Estimated

Description Module

Brief Summary

The objectives of this study are to assess the cerebral spinal fluid (CSF) pharmacokinetics and the plasma/CSF pharmacokinetic/pharmacodynamic relationship of ABT-384 in healthy male volunteers.

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

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
ABT-384	Experimental		Drug: ABT-384

Name	Type	Description	Arm Group Labels	Other Names
ABT-384	Drug	Doses will be administered daily for 5 days.	ABT-384

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)		Days -1 through 9
Assess Pharmacokinetics (i.e., ABT-384 and possible metabolite levels) and Pharmacodynamics (i.e., biomarkers of drug effect)		Days 1, 4 through 9

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age is between 18 and 55 years
Judged to be in a condition of general good health based on the results of medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG

Exclusion Criteria:

Use of protocol-prohibited medications within 2 weeks prior to study drug administration.
Positive urine drug screen for non-prescribed drugs of abuse including alcohol.
Receipt of any drug depot by injection within 30 days prior to study drug administration.
Receipt of any investigational product within 6 weeks prior to study drug administration.
History of significant sensitivity or allergy to any drug.
History of drug or alcohol abuse.
Positive test result for HAV, HBsAg, HCV or HIV.
Donation or loss of 550 mL or more blood volume or receipt of any blood product within 3 months prior to study drug administration.
Contraindication for lumbar puncture (e.g., lumbar scoliosis, coagulopathy, infected skin at puncture site)
Current enrollment in another clinical study.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 23882		Glendale	California	91206	United States

Intervention Browse Module

MeSH Terms

ID	Term
C584004	N-(5-(aminocarbonyl)tricyclo(3.3.1.13,7)dec-2-yl)-alpha,alpha-dimethyl-4-(5-(trifluoromethyl)-2-pyridinyl)-1-piperazineacetamide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided