TA-8995-05: DDI
Research type
Research Study
Full title
A Phase I, Open Label Study to Assess the Effects of TA-8995 on the Pharmacokinetics of Midazolam and Digoxin in Healthy Male Subjects
IRAS ID
147789
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Xention Ltd
Eudract number
2014-000232-42
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).
Dyslipidaemia itself does not generally exhibit symptoms, but it can lead to symptomatic vascular (blood vessel) disease including coronary artery disease (heart blood vessel) and peripheral arterial disease. While there are a number of genetic and lifestyle factors which contribute to the development of vascular disease, dyslipidaemia is one of the most prominent risk factors; therefore, normalisation of the lipid profile has been a major target in cardiovascular (heart and blood vessels) protection strategies.
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 can 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.
In this study, healthy male subjects will receive oral doses of midazolam and digoxin alone then in combination with the study drug. Midazolam and digoxin are both used as probe drugs in clinical pharmacology studies to evaluate certain drug interactions.
Each subject will participate in one treatment period residing in the unit for a period of 16 days. Subject participation is expected to last up to 6 weeks from the time of screening until the last post-study visit.
REC name
North East - York Research Ethics Committee
REC reference
14/NE/0021
Date of REC Opinion
26 Feb 2014
REC opinion
Favourable Opinion