ATX-101-08-10: ATX-101 Abdominoplasty
Sponsor
Kythera Biopharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00835952
Collaborator
(none)
14
2
1
5
7
1.4
Study Details
Study Description
Brief Summary
Histopathological study of abdominal fat excised from subjects undergoing abdominoplasty
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated 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
:
Nov 1, 2008
Actual Primary Completion Date
:
Mar 1, 2009
Actual Study Completion Date
:
Apr 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ATX-101
|
Drug: ATX-101
ATX-101 single doses
|
Outcome Measures
Primary Outcome Measures
- Adverse events, laboratory test results, physical examinations [1 - 28 days]
Secondary Outcome Measures
- Histopathology [1 - 28 Days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
25 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Healthy subjects undergoing planned abdominoplasty
Exclusion Criteria:
- History of interventions in the abdominal area
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Francisco | California | United States | ||
| 2 | Santa Monica | California | United States |
Sponsors and Collaborators
- Kythera Biopharmaceuticals
Investigators
- Study Director: Patricia Walker, M.D., Ph.D., Kythera Biopharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00835952
Other Study ID Numbers:
- ATX-101-08-10
First Posted:
Feb 4, 2009
Last Update Posted:
Jan 27, 2010
Last Verified:
Jan 1, 2010