JPBS: Absolute Bioavailability Study of LY2835219 in Healthy Subjects
Research type
Research Study
Full title
Protocol I3Y-MC-JPBS: An Absolute Bioavailability Study of LY2835219 in Healthy Subjects Using the Intravenous Tracer Method
IRAS ID
159022
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
LY2835219 is a new anti-cancer drug being investigated in this study. It is being developed with an aim to help cancer patients, by stopping tumour growth.
The injectable (infusion) formulation of the Study Drug will be radiolabelled with Carbon 13 (13C). Radiolabelled means that the drug has an invisible radioactive tag, allowing us to monitor the drug more closely in the body.
Up to 15 volunteers are planned to take part in this single site research study
Volunteers will receive a total of two doses of the Study Drug.
1) A single oral dose of 200 mg of the Study Drug will be administered as capsules, with a glass of water.
2) A single intravenous ( through the vein ) dose of approximately 0.4 mg of radiolabelled Study drug will be administered as an intravenous infusion (via a tube linked to a small needle in the vein) over 15 minutes, starting approximately 6 hours after the oral dose.
The Study involves volunteers coming to the Unit on at least 3 occasions, over a period of approximately 7 weeks. These visits will consist of one screening visit, one Study visit and then one follow-up visit.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1118
Date of REC Opinion
12 Sep 2014
REC opinion
Further Information Favourable Opinion