Back to resultsStudy of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects
Primary Purpose
Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ATL-962
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Pharmacokinetics, Pharmacodynamics
Eligibility Criteria
Inclusion Criteria: Obese, otherwise-healthy subjects Body mass index 30-45kg/m2 Exclusion Criteria: Women who are pregnant or breast feeding Any drug treatment within 2 weeks of commencement of dosing in this study
Sites / Locations
- SFBCI
Outcomes
Primary Outcome Measures
Pharmacokinetics of metabolites of ATL-962
Secondary Outcome Measures
Effect of ATL-962 on faecal fat excretion
Safety and tolerability of ATL-962
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00148382
Brief Title
Study of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects
Official Title
Randomized, Double Blind, Parallel Group, Repeat Dose Pharmacokinetic and Pharmacodynamic Study of Four Doses of ATL-962 (40mg, 80mg, 120mg 240mg) in Otherwise-Healthy Obese Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alizyme
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the amount of metabolites of ATL-962 in the blood and to investigate the effect of ATL-962 on the amount of fat that is excreted in the faeces in subjects who are obese
Detailed Description
Obesity is a significant and increasing clinical problem. There is a need for effective therapeutic agents to help people reduce weight. ATL-962 is a lipase inhibitor which could reduce the amount of fat absorbed from a person's diet, leading to weight reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Pharmacokinetics, Pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ATL-962
Primary Outcome Measure Information:
Title
Pharmacokinetics of metabolites of ATL-962
Secondary Outcome Measure Information:
Title
Effect of ATL-962 on faecal fat excretion
Title
Safety and tolerability of ATL-962
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Obese, otherwise-healthy subjects
Body mass index 30-45kg/m2
Exclusion Criteria:
Women who are pregnant or breast feeding
Any drug treatment within 2 weeks of commencement of dosing in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Galitz
Organizational Affiliation
SFBCI
Official's Role
Principal Investigator
Facility Information:
Facility Name
SFBCI
City
Miami
State/Province
Florida
ZIP/Postal Code
33181
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the Blood Levels and Effects of ATL-962 on Fat Excretion in Obese Subjects
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