TA-8995-04:TQT
Research type
Research Study
Full title
A Phase I, Single-Centre, Randomized, Placebo and Positive-Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects
IRAS ID
147791
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Xention Ltd
Eudract number
2014-000509-11
ISRCTN Number
n/a
Research summary
TA-8995 is being developed as a potential treatment for patients with dyslipidaemia (abnormal amounts of cholesterol and/or fat in the blood), administered in addition to a healthy heart diet, alone or in combination with a statin (licensed standard treatment).
People with high levels of lipids in their blood are at increased risk of developing heart diseases. Half of the UK population have blood cholesterol levels that put them at risk of developing heart disease. This shows the extent of this problem and the importance of developing effective treatment options.
Current strategies for the treatment of dyslipidaemia include both therapeutic lifestyle changes (dietary, weight loss, exercise) and drug therapy. However, there are safety issues associated with the drug therapies that limit their clinical use. Considering the unmet medical need and the potential benefit of cardiovascular risk reduction, TA-8995, is being developed by the sponsor for the treatment of patients with dyslipidaemia. TA-8995 has shown a favourable safety and efficacy profile to date which has prompted further clinical development.
The study drug (TA-8995) has been tested in 2 previous clinical trials to date in which a total of 123 healthy subjects were exposed to the study drug.
This study is about the safety of TA-8995 and will look at whether the study drug has any effect on the electrical activity of the heart.
In this study, healthy male and female subjects will be randomly assigned to receive a single oral dose of the study drug, or a placebo, or moxifloxacin (marketed drug with known minor effects on the electrical activity of the heart).
Each subject will participate in one treatment period residing in the unit for a period of 3 days. Subject participation is expected to last up to 6 weeks from the time of screening till the last post-study visit.REC name
North East - York Research Ethics Committee
REC reference
14/NE/0022
Date of REC Opinion
25 Apr 2014
REC opinion
Further Information Favourable Opinion