Pharmacokinetic Study of ABT-126 in Healthy Volunteers | NCT00959634

Studies
Pharmacokinetic Study of ABT-126 in Healthy Volunteers

NCT00959634

Sponsor

Abbott

Status

Completed

Last Update Posted

Nov 3, 2010Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

ABT-126
Placebo

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

Sep 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

Aug 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Not provided

First Submitted Date

Aug 12, 2009

First Submission Date that Met QC Criteria

Aug 13, 2009

First Posted Date

Aug 14, 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

Nov 2, 2010

Last Update Posted Date

Nov 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of a healthy volunteer.

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Dose 1 BID	Drug: ABT-126
2	Experimental	Dose 2 BID	Drug: ABT-126
3	Placebo Comparator	Placebo BID	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABT-126	Drug	Dose administered twice daily on Study Days 1-10	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse events assessment, physical examination, brief neurological examination)		One day before dosing through day of last dose and up to 6 days after last dose
ABT-126 levels in blood (plasma)		First dose through last dose and up to 192 hours after last dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male and female subjects between 18 and 50 years of age
If female, subject must be postmenopausal for at least 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
If male, subject must be surgically sterile (vasectomy) or agrees to use a barrier method (i.e., condom) of birth control starting on the first day of confinement until 30 days after the last study drug administration

Exclusion Criteria:

Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis
History of diabetes, cancer (except basal cell carcinoma of the skin), or any clinically significant cardiovascular, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, neurologic or psychiatric disease or disorder
Presence of any uncontrolled medical illness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 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# 22863		Austin	Texas	78744	United States

Intervention Browse Module

MeSH Terms

ID	Term
C000618299	ABT-126

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided