To Evaluate the Safety, Tolerability and to Compare the Pharmacokinetic Profile of ATX-101
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/7/2016 |
Start Date: | October 2011 |
End Date: | December 2011 |
Phase 1, Open-Label, Crossover, Safety and Pharmacokinetic Study of ATX-101 (Sodium Deoxycholate Injection) Following Subcutaneous Injections in the Submental and Abdominal Areas
The objectives of this trial are to evaluate the safety and tolerability of ATX-101
injections and to compare the pharmacokinetic profile of ATX-101 administered into
subcutaneous fat in the submental area and abdomen.
injections and to compare the pharmacokinetic profile of ATX-101 administered into
subcutaneous fat in the submental area and abdomen.
Inclusion Criteria:
1. Presence of submental fat graded by the investigator as 3 or 4 using the SMF Rating
Scale (Appendix C) as a guideline.
2. Sufficient submental and abdominal fat such that the protocol-specified number of
injections can be safely administered.
3. 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 for the first confinement period, 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.
4. A normal result on coagulation tests (PT, PTT) obtained within 28 days before
subject's first dosing session.
5. Serum hemoglobin test result of 12.0 g/dL or greater and negative hepatitis B,
hepatitis C, and HIV test result within 28 days before the dose of study material.
6. Ability to comply with and understand the visit schedule and all of the
protocol-specified tests and procedures.
7. 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.
8. Signed informed consent obtained before any study-specific procedure is conducted.
Exclusion Criteria:
1. History of any intervention to treat submental or abdominal fat (e.g., liposuction,
surgery, or lipolytic agents).
2. History of trauma associated with the chin, neck, or abdominal areas, which in the
judgment of the investigator may affect evaluation of safety or efficacy of
treatment.
3. 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.
4. Prominent platysmal bands at rest that interfere with the evaluation of submental
fat.
5. Evidence of any cause of enlargement in the submental or abdominal area other than
localized subcutaneous fat.
6. Obesity as defined by a body mass index (BMI) > 34 at the screening visit. Refer to
Appendix B.
7. 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.
8. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological
disease, uncontrolled hypertension, thyroid dysfunction), 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.
9. Treatment with fish oil, aspirin, or nonsteroidal anti-inflammatory agents (NSAIDS),
except acetaminophen, within seven days before dosing, or any anticipated need for
agents with anticoagulative effects (e.g., warfarin, heparin) during the course of
the trial.
10. Treatment with oral anticoagulants (e.g., warfarin) within 30 days before dosing with
study material.
11. Expected to require treatment with any systemic medication during the study period
(excluding any protocol-specified treatments)
12. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers
in the neck or chin area within 12 months before the first treatment session, or
botulinum toxin injections in the neck or chin area within 6 months before the first
treatment session.
13. History of sensitivity to any components of the study material or to topical
anesthetics (e.g., lidocaine, benzocaine, novocaine).
14. History of drug or alcohol abuse, in the judgment of the investigator, within two
years before the dose of study material.
15. 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 the dose of study material.
16. Previous enrollment into a trial of ATX-101.
17. Treatment with an investigational agent within 30 days before dosing.
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