I6F-MC-JJCG Bioavailability study of LY3039478 in healthy subjects
Research type
Research Study
Full title
An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method
IRAS ID
209589
Contact name
Jim Bush
Contact email
Sponsor organisation
Eli Lilly and Company
Eudract number
2016-001073-33
Duration of Study in the UK
0 years, 1 months, 26 days
Research summary
LY3039478 is an investigational medicinal product (IMP) which is being developed for helping people with cancer.
LY3039478 has been tested up to a dose of 100mg in cancer patients and up to 75 mg in healthy volunteers. The results from the studies done in healthy volunteers so far indicate that the drug was well tolerated.
The main intention of this study is to determine the absolute bioavailability (Percentage of drug absorbed in to blood after administration) of a 75 mg oral dose compared to a very small intravenous (into blood vessel) dose of 350 μg of 13C-labelled LY3039478.
Subjects will participate in a screening visit, a single study period, and a follow-up visit. Subjects will be admitted to the clinical research unit (CRU) on the day prior to dosing (Day -1) and will remain resident until after the Day 3 (48 hour post-dose) assessments. On Day 1 following an overnight fast of at least 10 hours, subjects will receive a single oral dose of 75 mg LY3039478. Approximately 15 minutes after the 75 mg oral dose of unlabelled LY3039478,subjects will be administered an IV infusion of approximately 350 μg 13C 15N 2H-LY3039478.
Up to 12 subjects may be enrolled so that at least 8 subjects complete the study.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0199
Date of REC Opinion
11 Aug 2016
REC opinion
Favourable Opinion