Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Dose-Escalation Safety and Pharmacokinetic Study of ATX-101
This study is currently recruiting participants.
Verified by Kythera Biopharmecuticals, July 2008
Sponsored by: Kythera Biopharmecuticals
Information provided by: Kythera Biopharmecuticals
ClinicalTrials.gov Identifier: NCT00618709
  Purpose

The purpose of this research is to evaluate the safety and pharmacokinetic profile of single doses of ATX-101


Condition Intervention Phase
Healthy
 Drug: ATX-101
 Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area

Further study details as provided by Kythera Biopharmecuticals:

Primary Outcome Measures:
  • Safety: Laboratory tests, medical evaluations [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic profile [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2008
Estimated Study Completion Date: October 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
ATX-101 0.5% concentration
Drug: ATX-101
Single doses at concentrations of 0.5%, 1.0%, 2.0% and 4.0%
2: Experimental
ATX-101 1.0% concentration
Drug: ATX-101
Single doses at concentrations of 0.5%, 1.0%, 2.0% and 4.0%
3: Experimental
ATX-101 1.0% and 2.0% concentrations
Drug: ATX-101
Single doses at concentrations of 0.5%, 1.0%, 2.0% and 4.0%
4: Experimental
ATX-101 2.0% and 4.0% concentrations
Drug: ATX-101
Single doses at concentrations of 0.5%, 1.0%, 2.0% and 4.0%

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males or nonpregnant females
  • Age 18 to 65
  • Sufficient submental fat for injections
  • Signed informed consent

Exclusion Criteria:

  • Prior interventions in the chin or neck area
  • History or presence of drug or alcohol abuse
  • Treatment with an investigational agent within 30 days before the dose
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00618709

Contacts
Contact: Dennis Swearingin, M.D. 602-437-0097

Locations
United States, Arizona
MDS Pharma Services Recruiting
Tempe, Arizona, United States, 85283
Contact: Dennis Swearingin, M.D.            
Principal Investigator: Dennis Swearingin, M.D.            
Sponsors and Collaborators
Kythera Biopharmecuticals
Investigators
Principal Investigator: Dennis Swearingin, M.D. MDS Pharma Services
  More Information

Responsible Party: Kythera Biopharmaceuticals, Inc. ( Daniel R. Lee, M.S., Director, Clinical Affairs )
Study ID Numbers: ATX-101-07-08, ATX-101-07-08
Study First Received: January 23, 2008
Last Updated: July 8, 2008
ClinicalTrials.gov Identifier: NCT00618709  
Health Authority: United States: Food and Drug Administration

Keywords provided by Kythera Biopharmecuticals:
Healthy volunteers

Study placed in the following topic categories:
Deoxycholic Acid
Healthy

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services