- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00918606
An Evaluation of the Pharmacokinetics and Safety of LIPO-102 in Healthy Volunteers
March 19, 2015 updated by: Neothetics, Inc
An Evaluation of the PK and Safety of LIPO-102 in Healthy Volunteers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LIPO-102
|
LIPO-102
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: Laboratory tests, medical exams
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
June 10, 2009
First Submitted That Met QC Criteria
June 10, 2009
First Posted (Estimate)
June 11, 2009
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 19, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- LIPO-102-CL-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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