PRC-4016 AME
Research type
Research Study
Full title
[14C] PRC-4016 (Icosabutate ) - A Phase I, Open-Label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects
IRAS ID
159220
Contact name
Jim Bush
Contact email
Sponsor organisation
Pronova BioPharma Norge AS (now part of BASF)
Eudract number
2014-002304-24
Research summary
PRC-4016 is being developed as a potential treatment for mixed Dyslipidaemia (abnormal levels of cholesterol and/or fat (lipids) in blood).
This Study will involve a single dose of 600 mg 14C radio labelled PRC-4016. This means that a radioactive substance (Carbon 14) will be attached to the Study Drug which will help us to investigate the Study Drug and its breakdown products to find out how much of these pass from the blood into urine and faeces. Up to 6 volunteers will participate in this Study.
This study is designed to evaluate how much of the Study Drug gets into the blood stream and how long it takes the body to remove it following a single oral, pattern of breakdown products of the Study Drug in blood, urine and faeces and the safety of the Study Drug and any side effects that might be associated with it.
This is an Open-Label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects.
Subjects will check-in to the Unit in the day before dosing (Day -1) and stay at the Unit until at least the 8th day after dosing. Depending on how the body eliminates the radioactivity, subjects may be asked to stay in the Unit up until Day 10 to continue 24 hour urine and faeces collections. Blood samples may also be collected daily. If the release criteria are still not met by 216 hours postdose (Day 10), subjects will be asked to collect 24-hour excreta samples on a non-residential basis on up to 2 further occasions to allow extrapolation of urinary and faecal excretion. If needed, the 2 additional 24 hour collections will occur on Day 14 (± 1 day) and Day 21 (± 1 day). If on the second occasion the subject has still not met the desired criterion then the subject will be discharged from the study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
14/SC/1082
Date of REC Opinion
17 Jul 2014
REC opinion
Further Information Favourable Opinion