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

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ClinicalTrials.gov Identifier: NCT00918606
Recruitment Status : Completed
First Posted : June 11, 2009
Last Update Posted : March 24, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.

Condition or disease Intervention/treatment Phase
Subcutaneous Adipose Tissue Reduction Drug: LIPO-102 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2009
Primary Completion Date : June 2009
Study Completion Date : June 2009
Arms and Interventions

Arm Intervention/treatment
Experimental: LIPO-102 Drug: LIPO-102
LIPO-102


Outcome Measures

Primary Outcome Measures :
  1. Safety: Laboratory tests, medical exams [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 24 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT00918606


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

Responsible Party: Neothetics, Inc
ClinicalTrials.gov Identifier: NCT00918606     History of Changes
Other Study ID Numbers: LIPO-102-CL-01
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015