Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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

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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00918606

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. 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 processed this record on March 01, 2015