Phase I study to determine the BE of TA-8995 in healthy males
Research type
Research Study
Full title
A phase 1, randomised, open label, cross over bioequivalence study of capsule and tablet formulations of TA 8995 in healthy male subjects
IRAS ID
178616
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Xention Ltd
Eudract number
2015-001390-40
Duration of Study in the UK
0 years, 3 months, 4 days
Research summary
The study drug (TA-8995) has been developed as a potential treatment for people with high levels of cholesterol and/or fat (lipids) in their blood.
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.
A total of five clinical studies have been completed to date, in which over 400 healthy volunteers and patients have received the study drug. In these studies, single doses of TA-8995 up to 150 mg and multiple doses of TA-8995 up to 25 mg once daily for 21 days were generally well tolerated and safe.
In this study, healthy male subjects will participate in 2 treatment periods. Subjects will receive a single oral dose of 5 mg TA 8995 as either a capsule or tablet in Treatment Period 1, and vice versa in Treatment Period 2. There will be at least a 41 day wash out period between the doses.
All subjects will return for a safety visit 7 to 14 days post-dose in each treatment period.
The expected duration of subject participation (from screening to post-study) is approximately 12 weeks.REC name
North East - York Research Ethics Committee
REC reference
15/NE/0111
Date of REC Opinion
13 Apr 2015
REC opinion
Favourable Opinion