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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00835952
First Posted: February 4, 2009
Last Update Posted: January 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kythera Biopharmaceuticals
  Purpose
Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty

Condition Intervention Phase
Characteristics of Subcutaneous Fat Drug: ATX-101 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by Kythera Biopharmaceuticals:

Primary Outcome Measures:
  • Adverse events, laboratory test results, physical examinations [ Time Frame: 1 - 28 days ]

Secondary Outcome Measures:
  • Histopathology [ Time Frame: 1 - 28 Days ]

Estimated Enrollment: 14
Study Start Date: November 2008
Study Completion Date: April 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATX-101 Drug: ATX-101
ATX-101 single doses

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects undergoing planned abdominoplasty

Exclusion Criteria:

  • History of interventions in the abdominal area
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835952


Locations
United States, California
San Francisco, California, United States
Santa Monica, California, United States
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
Study Director: Patricia Walker, M.D., Ph.D. Kythera Biopharmaceuticals, Inc.
  More Information

Responsible Party: Director, Clinical Affairs, Kythera Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00835952     History of Changes
Other Study ID Numbers: ATX-101-08-10
First Submitted: February 3, 2009
First Posted: February 4, 2009
Last Update Posted: January 27, 2010
Last Verified: January 2010