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

This study has been completed.
Sponsor:
Information provided by:
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT00918606
First received: June 10, 2009
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Lithera, 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 ]

Estimated 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
LIPO-102

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918606

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

No publications provided

Responsible Party: Vice President, Regulatory Affairs and Quality, Lithera, Inc.
ClinicalTrials.gov Identifier: NCT00918606     History of Changes
Other Study ID Numbers: LIPO-102-CL-01
Study First Received: June 10, 2009
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014