Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

This study has been completed.

First Received: January 23, 2008 Last Updated: February 3, 2009 History of Changes

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

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 ]

Enrollment:	24
Study Start Date:	January 2008
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental ATX-101	Drug: ATX-101 ATX-101 single dose

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618709

Locations

Sponsors and Collaborators

Kythera Biopharmecuticals

Investigators

Principal Investigator:

Dennis Swearingin, M.D.

MDS Pharma Services

More Information

No publications provided

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:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00618709 History of Changes
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 May 07, 2009