Dose-Escalation Safety and Pharmacokinetic Study of ATX-101

Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate for Injection) Following Subcutaneous Injections in the Submental Area

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ATX-101

Detailed Description

This is a single center, open-label, dose-escalation study in which subjects will receive 4 different dosage concentrations (3 dosing paradigms) of ATX-101 in a single dosing session.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • MDS Pharma Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; ATX-101 (1 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid	Drug: ATX-101; ATX-101 single dose
Experimental: Cohort 2; ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid	Drug: ATX-101; ATX-101 single dose
Experimental: Cohort 3; 3 subgroups in Cohort 3: 3a: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 3b: ATX-101 (2 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 3c: ATX-101 (2 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid	Drug: ATX-101; ATX-101 single dose
Experimental: Cohort 4; 3 subgroups in Cohort 4: 4a: ATX-101 (8 mg/cm2) at a volume of 0.2 ml on a 1.0 cm grid 4b: ATX-101 (4 mg/cm2) at a volume of 0.2 ml on a 0.7 cm grid 4c: ATX-101 (4 mg/cm2) at a volume of 0.4 ml on a 1.0 cm grid	Drug: ATX-101; ATX-101 single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessed by: Laboratory tests	12 weeks
Safety assessed by: medical evaluations	24 weeks
Safety assessed by: ECG results	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic profile	Cmax, tmax, AUC	24 hours, before and after dosing

Other Outcome Measures

Outcome Measure	Time Frame
Pain assessed by visual analog scale	24 weeks

Collaborators and Investigators

• Sponsor: Kythera Biopharmaceuticals
• Investigators: Principal Investigator: Dennis Swearingin, M.D., MDS Pharma Services; Study Director: Frederick Beddingfield, M.D., Sponsor GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: January 23, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (Estimate): February 20, 2008

Study Record Updates

• Last Update Posted (Estimate): May 30, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Other Study ID Numbers: ATX-101-07-08