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
| ISRCTN | ISRCTN35772094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35772094 |
| ClinicalTrials.gov number | NCT00148382 |
| Secondary identifying numbers | ATL-962/191/CL |
- Submission date
- 06/09/2005
- Registration date
- 16/09/2005
- Last edited
- 19/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lawrence Galitz
Scientific
Scientific
SFBC International, Inc
11190 Biscayne Boulevard
Miami
FL 33181
United States of America
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obesity |
| Intervention | ATL-962 40 mg, 80 mg, 120 mg or 240 mg three times a day for 14 days |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2005 |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Not Specified |
| Target number of participants | 80 |
| Key inclusion criteria | Obese, otherwise-healthy, subjects, aged 18-40, with a body mass index between 30 kg/m2 and 45 kg/m2. |
| Key exclusion criteria | 1. Women who are pregnant or breast feeding 2. Any drug treatment within 2 weeks of commencement of dosing in this study |
| Date of first enrolment | 01/04/2005 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- United States of America
Study participating centre
SFBC International, Inc
Miami
FL 33181
United States of America
FL 33181
United States of America
Sponsor information
Alizyme (UK)
Industry
Industry
Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
| Phone | +44 (0)1223 896 000 |
|---|---|
| Medical.Information@alizyme.co.uk | |
| Website | www.alizyme.com |
Funders
Funder type
Industry
Alizyme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/02/2020: No publications found, all search options exhausted, study status unverified.
19/02/2020: The NCT code has been added.
