NCT00918606

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2009

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

June 10, 2009

Last Update Submit

March 19, 2015

Conditions

Subcutaneous Adipose Tissue Reduction

Outcome Measures

Primary Outcomes (1)

  • Safety: Laboratory tests, medical exams

    4 weeks

Secondary Outcomes (1)

  • Pharmacokinetics

    24 hours

Study Arms (1)

LIPO-102

EXPERIMENTAL
Drug: LIPO-102

Interventions

LIPO-102DRUG

LIPO-102

LIPO-102

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Known hypersensitivity to study drugs
  • Treatment with an investigational agent within 30 days before first dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Baltimore, Maryland, United States

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 11, 2009

Study Start

February 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

US(1)