Study To Evaluate The Effects Of GW856553 On Endothelial Function/Vascular Compliance In Subjects… (NCT00474864) | Clinical Trial Compass
CompletedPhase 2
Study To Evaluate The Effects Of GW856553 On Endothelial Function/Vascular Compliance In Subjects With Dyslipidaemia.
United Kingdom66 participantsStarted 2007-07
Plain-language summary
The rationale for this study is to determine whether GW856553 (7.5mg BD for 28 days) has an effect on endothelial function in dyslipidaemic subjects as assessed by venous occlusion plethysmography using brachial artery acetylcholine infusion. This will establish consistency with preclinical findings, as well as confirm a physiologic human response at the current safe maximal dose. Safety (specifically serum liver function testing) and tolerability will also be evaluated in this trial.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy adult male and females between 18 and 75 years of age, inclusive.
* To be eligible, female subjects must have a negative pregnancy test (i.e. Urine or serum β-hCG (for females) and be of:
* non-childbearing potential (i.e. physiologically incapable of becoming pregnant). This includes any female who is post-menopausal.
OR
* childbearing potential and agree to commit to one of the protocol-approved methods of contraception.
* Body weight \> 50 kg and body mass index (BMI) between 19 and 32kg/m2
* Subjects with high LDLc levels, as per NCEP ATPIII criteria:fasting LDLc level \> 4.1 mmol/L (160 mg/dL), inclusive. Fasting TG level should be \< 4.5mmol/L (400 mg/dL)
* A signed and dated written informed consent prior to admission to the study
* The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
The following criteria must apply only for subjects undergoing FDG-PET/CT and MRI
* All diabetics will be excluded from the scanning sub-study involving MRI and FDGPET/CT.
* Subjects will be excluded who have previously participated in a research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv effective radiation dose in addition to natural background radiation, in the previous 3 years including the dose from …
What they're measuring
1
Forearm blood flow ratio measured at baseline and day 28.