Phase I Study to Assess the AME and PK of TA-8995 in healthy males
Research type
Research Study
Full title
A Phase I Study to Assess the Mass Balance Recovery, Pharmacokinetics, Metabolism and Excretion of 14C TA 8995 in Healthy Male Subjects
IRAS ID
168477
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Xention Ltd
Eudract number
2014-004385-16
Duration of Study in the UK
0 years, 2 months, 4 days
Research summary
TA 8995 is the research drug. TA-8995 is for the treatment of patients with dyslipidaemia ( high cholesterol levels )
This will be an open label (staff and the volunteer will know the drug they receive), single oral dose study in healthy male volunteers. Six volunteers will participate in the study and will be studied in a single group.
This is a radiolabelled study. Radiolabelled means that the drug has an invisible radioactive tag, allowing us to monitor the drug more closely when it breakdown in the body.
Each volunteer will receive a single 10mg oral dose of (14C) TA 8995 in the fasted state.
Each volunteer will reside at the clinical research unit (CRU) from Day 1 (day volunteers receive the research drug) until at least the morning of Day 22. Urine and faecal samples will be collected for radioactivity counting.
Vomitus (if produced during the first 48 hours after dosing) will be collected for radioactivity counting.
Volunteers may be discharged earlier on the condition that:
• there are no medical reasons for a longer stay; and
• sufficient recovery of the administered radioactivity has been achieved (more than 90% of the administered dose); or
• the total excretion (urine + faeces) per 24 hours is less than 1% of the administered dose during 2 consecutive 24 hour intervals.After Day 22 volunteers may be asked to collect 24 hour excreta samples on up to 2 further occasions on a non-residential basis to allow detect of urinary and faecal excretion.
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0007
Date of REC Opinion
15 Jan 2015
REC opinion
Favourable Opinion