Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00148382
Protocol/serial number
ATL-962/191/CL
Study information
Scientific title
Randomized, double-blind, parallel group, repeat dose pharmacokinetic and pharmacodynamic study of four doses of ATL-962 (40 mg, 80 mg, 120 mg 240 mg tid) in otherwise-healthy, obese volunteers
Acronym
Study hypothesis
What are the pharmacokinetics of the metabolites of ATL-962 and what effect does ATL-962 have on faecal fat excretion in obese subjects
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Obesity
Intervention
ATL-962 40 mg, 80 mg, 120 mg or 240 mg three times a day for 14 days
Intervention type
Drug
Phase
Not Specified
Drug names
ATL-962
Primary outcome measure
Pharmacokinetics of the metabolites of ATL-962, namely ATL-1143 and ATL1277
Secondary outcome measures
Change from baseline in faecal fat excretion.
Safety and tolerability
Overall trial start date
01/04/2005
Overall trial end date
31/07/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Obese, otherwise-healthy, subjects, aged 18-40, with a body mass index between 30 kg/m2 and 45 kg/m2.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
80
Participant exclusion criteria
1. Women who are pregnant or breast feeding
2. Any drug treatment within 2 weeks of commencement of dosing in this study
Recruitment start date
01/04/2005
Recruitment end date
31/07/2005
Locations
Countries of recruitment
United States of America
Trial participating centre
SFBC International, Inc
Miami
FL 33181
United States of America
Sponsor information
Organisation
Alizyme (UK)
Sponsor details
Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
+44 (0)1223 896 000
Medical.Information@alizyme.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Alizyme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list