NCT00148382

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_1 obesity

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

April 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

April 11, 2007

Status Verified

April 1, 2007

First QC Date

September 7, 2005

Last Update Submit

April 10, 2007

Conditions

Obesity

Keywords

ObesityPharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics of metabolites of ATL-962

Secondary Outcomes (2)

  • Effect of ATL-962 on faecal fat excretion

  • Safety and tolerability of ATL-962

Interventions

ATL-962DRUG

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Obese, otherwise-healthy subjects
  • Body mass index 30-45kg/m2

You may not qualify if:

  • Women who are pregnant or breast feeding
  • Any drug treatment within 2 weeks of commencement of dosing in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SFBCI

Miami, Florida, 33181, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

cetilistat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lawrence Galitz

    SFBCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

April 1, 2005

Study Completion

July 1, 2005

Last Updated

April 11, 2007

Record last verified: 2007-04

Locations

US(1)