NCT01632917

Open-Label Pharmacokinetic Study of Final Formulations of ATX-101

Phase 1, Open-Label, Randomized, Safety and Pharmacokinetic Study of Two Final Formulations of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the Submental Fat

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.

Detailed description

The objectives of this trial are to evaluate the safety and tolerability of ATX-101 injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations that are expected to be the final formulations. ATX-101 will be administered into the submental fat as subcutaneous injections using the maximum proposed dosing regimen that is intended for labeling.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ATX-101 - U.S.	US ATX-101, 10 mg/mL, one dosing session in the submental area
DRUG	ATX-101 - EU	EU ATX-101, 10 mg/mL, one dosing session in the submental area

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-07-03
• Last updated: 2012-09-25

Locations

1 site across 1 country: United States