An Evaluation of the Pharmacokinetics and Safety of LIPO-102 in Healthy Volunteers

This study has been completed.
Information provided by (Responsible Party):
Neothetics, Inc Identifier:
First received: June 10, 2009
Last updated: March 19, 2015
Last verified: March 2015
An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.

Condition Intervention Phase
Subcutaneous Adipose Tissue Reduction
Drug: LIPO-102
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Neothetics, Inc:

Primary Outcome Measures:
  • Safety: Laboratory tests, medical exams [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102 Drug: LIPO-102


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male and non pregnant female
  • 18-55 years old
  • Sufficient abdominal fat for injections
  • Signed informed consent

Exclusion Criteria:

  • Known hypersensitivity to study drugs
  • Treatment with an investigational agent within 30 days before first dose
  Contacts and Locations
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Please refer to this study by its identifier: NCT00918606

United States, Maryland
Baltimore, Maryland, United States
Sponsors and Collaborators
Neothetics, Inc
  More Information

Responsible Party: Neothetics, Inc Identifier: NCT00918606     History of Changes
Other Study ID Numbers: LIPO-102-CL-01 
Study First Received: June 10, 2009
Last Updated: March 19, 2015
Health Authority: United States: Food and Drug Administration processed this record on May 26, 2016