ATX-101 Abdominoplasty (ATX-101-08-10)

January 25, 2010 updated by: Kythera Biopharmaceuticals

Phase 1, Open-label Study of the Safety, Tolerability, and Histological Effect of Single Doses of ATX-101 (Sodium Deoxycholate for Injection) Administered in Abdominal Fat in Subjects Undergoing Abdominoplasty

Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States
      • Santa Monica, California, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects undergoing planned abdominoplasty

Exclusion Criteria:

  • History of interventions in the abdominal area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATX-101
Drug: ATX-101
ATX-101 single doses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Histopathology
Time Frame: 1 - 28 Days
1 - 28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kythera Biopharmaceuticals

Investigators

  • Study Director: Patricia Walker, M.D., Ph.D., Kythera Biopharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

February 3, 2009

First Submitted That Met QC Criteria

February 3, 2009

First Posted (Estimate)

February 4, 2009

Study Record Updates

Last Update Posted (Estimate)

January 27, 2010

Last Update Submitted That Met QC Criteria

January 25, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • ATX-101-08-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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