NCT00835952

Brief Summary

Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 27, 2010

Status Verified

January 1, 2010

Enrollment Period

4 months

First QC Date

February 3, 2009

Last Update Submit

January 25, 2010

Conditions

Characteristics of Subcutaneous Fat

Outcome Measures

Primary Outcomes (1)

  • Adverse events, laboratory test results, physical examinations

    1 - 28 days

Secondary Outcomes (1)

  • Histopathology

    1 - 28 Days

Study Arms (1)

ATX-101

EXPERIMENTAL
Drug: ATX-101

Interventions

ATX-101DRUG

ATX-101 single doses

ATX-101

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects undergoing planned abdominoplasty

You may not qualify if:

  • History of interventions in the abdominal area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

San Francisco, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Study Officials

  • Patricia Walker, M.D., Ph.D.

    Kythera Biopharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

November 1, 2008

Primary Completion

March 1, 2009

Study Completion

April 1, 2009

Last Updated

January 27, 2010

Record last verified: 2010-01

Locations

US(2)