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

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ClinicalTrials.gov Identifier: NCT00835952
Recruitment Status : Completed
First Posted : February 4, 2009
Last Update Posted : January 27, 2010
Sponsor:
Information provided by:
Kythera Biopharmaceuticals

Brief Summary:
Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty

Condition or disease Intervention/treatment Phase
Characteristics of Subcutaneous Fat Drug: ATX-101 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
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
Study Start Date : November 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Experimental: ATX-101 Drug: ATX-101
ATX-101 single doses



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

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


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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

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.

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