Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01632917
Recruitment Status : Completed
First Posted : July 3, 2012
Last Update Posted : September 25, 2012
Sponsor:
Information provided by (Responsible Party):
Kythera Biopharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 29, 2012
First Posted Date  ICMJE July 3, 2012
Last Update Posted Date September 25, 2012
Study Start Date  ICMJE June 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
Safety of ATX-101 injections as assessed by incidence, severity and duration of AEs of ATX-101 administered into subcutaneous fat in the submental and abdomen area [ Time Frame: 8 days ]
Spontaneously reported adverse events, laboratory test results, and treatment area evaluations including, but not limited to evaluation of edema, bruising, dysphagia, dysphonia, erythema, dyspigmentation, induration, numbness, pain, paresthesia, and pruritus.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01632917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
To compare the pharmacokinetic profile (Cmax, tmax, AUC, half-life) of ATX-101 administered into subcutaneous fat in the submental area [ Time Frame: 8 days ]
Blood sampling at specified time points before and after dosing with ATX-101 for analysis of deoxycholate concentrations in the plasma.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label Pharmacokinetic Study of Final Formulations of ATX-101
Official Title  ICMJE 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
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: ATX-101 - EU
    Open Label study in which subjects will receive ATX-101 (one of the two formulations) in one dosing session in the submental area
    Intervention: Drug: ATX-101 - EU
  • Experimental: ATX-101 - US
    Open Label study in which subjects will receive ATX-101 (one of the two formulations) in one dosing session in the submental area
    Intervention: Drug: ATX-101 - U.S.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presence of sufficient submental fat into which 50 subcutaneous injections of ATX-101 spaced on a 1.0-cm grid can be safely administered based on the investigator's judgment.
  • Males or nonpregnant, nonlactating females who are aged 18 to 65 years, inclusive, on the date of dosing with ATX-101. Females must have a negative serum human chorionic gonadotropin (hCG) test result from a sample obtained during the screening period and after admission to the research facility, but before the dose of study material. Females of postmenopausal status must not have had menses for at least one year and if younger than 55 years of age must have a serum FSH level ≥ 35 mIU/mL. Females of childbearing potential must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
  • Serum hemoglobin test result of 11.0 g/dL or greater and negative hepatitis B, hepatitis C, and HIV test result within 28 days before the dose of study material.
  • Willing and able to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
  • Medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 28 days before dosing with study material for which the investigator identifies no clinically significant abnormality.
  • Signed informed consent obtained before any study-specific procedure is conducted.

Exclusion Criteria:

  • History of any intervention to treat submental fat (e.g. liposuction, surgery, or lipolytic agents).
  • History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety of treatment.
  • Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in a cosmetically unacceptable outcome.
  • Prominent platysmal bands at rest that interfere with the evaluation of submental fat.
  • Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat.
  • Body mass index (BMI) > 40.0 at the screening visit. Refer to Appendix B.
  • Use of tobacco or nicotine-containing products within 3 months prior to dose.
  • Any blood donation or significant blood loss within 56 days before the dose of study material or plasma donation within 7 days before the dose of study material.
  • A result on coagulation tests (PT, PTT) obtained within 28 days before the dose of study material that indicates the presence of any clinically significant bleeding disorder.
  • Any medical condition that would interfere with the assessment of safety in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
  • Treatment with fish oil, aspirin, or nonsteroidal anti-inflammatory agents (NSAIDS), except acetaminophen, within 7 days before dosing, or any anticipated need for agents with anticoagulative effects (e.g. warfarin, heparin) during the course of the trial.
  • Treatment with oral anticoagulants (e.g. warfarin) within 30 days before dosing with study material.
  • Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before dosing with the study material, or botulinum toxin injections in the neck or chin area within 6 months before dosing with the study material.
  • History of sensitivity to any components of the study material.
  • History of drug or alcohol abuse, in the judgment of the investigator, within two years before dosing with the study material.
  • Presence of a positive urine drug or alcohol screening test result obtained from a sample obtained during the screening period and/or after admission to the research facility for the confinement period, but before dosing with the study material.
  • Previous enrollment into a trial of ATX-101.
  • Treatment with an investigational device or agent within 30 days before dosing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01632917
Other Study ID Numbers  ICMJE ATX-101-12-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kythera Biopharmaceuticals
Study Sponsor  ICMJE Kythera Biopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Patricia Walker, MD, PhD Kythera Biopharmaceuticals, Inc
PRS Account Kythera Biopharmaceuticals
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP