ATX-101 Abdominoplasty | NCT00835952

Studies
ATX-101 Abdominoplasty

NCT00835952

Sponsor

Kythera Biopharmaceuticals

Status

Completed

Last Update Posted

Jan 27, 2010Estimated

Enrollment

14Estimated

Phase

Phase 1

Conditions

Characteristics of Subcutaneous Fat

Interventions

ATX-101

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

Jan 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

Nov 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Feb 3, 2009

First Submission Date that Met QC Criteria

Feb 3, 2009

First Posted Date

Feb 4, 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

Jan 25, 2010

Last Update Posted Date

Jan 27, 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

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

14Estimated

Label	Type	Description	Intervention Names
ATX-101	Experimental		Drug: ATX-101

Name	Type	Description	Arm Group Labels	Other Names
ATX-101	Drug	ATX-101 single doses	ATX-101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events, laboratory test results, physical examinations		1 - 28 days

Secondary Outcomes

Measure	Description	Time Frame
Histopathology		1 - 28 Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects undergoing planned abdominoplasty

Exclusion Criteria:

History of interventions in the abdominal area

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia Walker, M.D., Ph.D.	Kythera Biopharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		San Francisco	California		United States