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Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 Into Abdominal Fat Tissue

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: NCT01319916
Recruitment Status : Completed
First Posted : March 22, 2011
Last Update Posted : March 22, 2011
Sponsor:
Information provided by:
Kythera Biopharmaceuticals

Brief Summary:
Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 into Abdominal Fat Tissue

Condition or disease Intervention/treatment Phase
Healthy Drug: ATX-101 Phase 1

Detailed Description:
Phase 1, Open Label Study to Evaluate the Serum Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 (Sodium Deoxycholate Injection) into Abdominal Fat Tissue

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Study to Evaluate the Lipid and Adipokine Profiles Following Subcutaneous Injection of ATX-101 (Sodium Deoxycholate Injection) Into Abdominal Fat Tissue
Study Start Date : December 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Intervention Details:
  • Drug: ATX-101
    ATX-101 2mg/cm2


Primary Outcome Measures :
  1. Effects of ATX-101 on serum lipid and deoxycholate
    acute effects of ATX-101 on serum lipid and deoxycholate profile following subcutaneous administration into abdominal fat tissue.


Secondary Outcome Measures :
  1. Adipokine levels following subcutaneous administration of ATX-101
    To evaluate adipokine levels following subcutaneous administration of ATX-101 into abdominal fat tissue



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Healthy, non-smoking males and nonpregnant, nonlactating females who are 18 to 65 years of age, inclusive, on Day 1A.

    2. Body mass index (BMI) of 18.5 to ≤ 30.0 at within 28 days before the dose of study material.

    3. Stable weight (e.g., approximately ± 10 lbs), in the judgment of the investigator, for at least 3 months before Day 1A.

    4. Sufficient abdominal tissue surface for which 50 injections spaced on 1 cm grid (4 cm x 9 cm square) can be safely administered into fat tissue.

    5. Fasting glucose within normal limits (i.e., 75-100 mg/dL) at within 28 days before the dose of study material.

    6. Fasting hemoglobin A1c within normal limits for the laboratory designated for this trial (e.g., 4 - 5.9%) at within 28 days before the dose of study material.

    7. Fasting triglycerides within normal limits for the laboratory designated for this trial (e.g., < 150m/dL) at within 28 days before the dose of study material.

    8. Fasting cholesterol within normal limits for the laboratory designated for this trial (e.g., < 200 mg/dL) at within 28 days before the dose of study material.

    9. Females must have a negative serum human chorionic gonadotropin (hCG) test result from a sample obtained within 28 days before the beginning of the confinement period and again after admission to the research facility for the confinement period, but before the dose of study material. Females must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.

    10. Negative hepatitis B, hepatitis C, and HIV test results. 11. The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.

    12. The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations obtained within 28 days before Day 1A for which the investigator identifies no clinically significant abnormality.

    13. Signed informed consent obtained before any study-specific procedure is conducted

Exclusion Criteria:

  • 1. History of any intervention (e.g., liposuction) or trauma associated with the abdominal area, which in the judgment of the investigator, may affect subject's safety or other evaluations of treatment.

    2. Subjects who, for any reason, are on active diet, calorie restriction, or attempting to lose weight.

    3. Blood donation of 500 mL or blood transfusion within 60 days before Day 1A, or plasma donation within 7 days before Day 1A.

    4. Diagnosis of lipodosis (e.g., Gaucher, Niemann-Pick, or Fabry disease) or other confounding metabolic diseases.

    5. History of hypertriglyceridemia (triglycerides > 200 mg/dL), hypercholesterolemia (cholesterol > 240 mg/dL), or hyperlipidemia.

    6. Use of statins (e.g., Vitorin, Lipitor, Lopid) or other lipid-lowering agent (e.g., nicotinic acid) within 28 days or five (5) half-lives, whichever is greater, before Day 1A.

    7. History of diabetes or screening results indicative of diabetes. 8. Use of antiglycemic agents at any time before screening. 9. Use of any medication that results in systemic exposure beginning during the screening period.

    10. Any medical condition (e.g., respiratory, cardiovascular, renal, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction) that would interfere with laboratory or safety assessments, compromise the ability of the subject to undergo study procedures, or compromise the subject's ability to give informed consent.

    11. Treatment with oral anticoagulants (e.g., warfarin, heparin) within 10 days before Day 1A; anticipated need for agents with anticoagulative effects during the course of the trial.

    12. History of sensitivity to any components of the study material or topical anesthetics (e.g., lidocaine, benzocaine, novocaine).

    13. Previous enrollment into this trial or treatment with ATX-101 or agents containing deoxycholate.

    14. Treatment with an investigational agent within 28 days before Day 1A.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319916


Locations
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United States, North Dakota
Robert Cooper, M.D. Cetero Research
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Kythera Biopharmaceuticals
Investigators
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Study Director: Patricia Walker, MD, PhD Kythera Biopharmaceuticals
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Responsible Party: Daniel R. Lee, M.S., Director, Clinical, Kythera Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01319916    
Other Study ID Numbers: ATX-101-10-18
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: March 22, 2011
Last Verified: March 2011