Bioavailability Study of LY3314814 in Healthy Subjects using IV tracer
Research type
Research Study
Full title
An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method
IRAS ID
222322
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Eli Lilly & Company
Eudract number
2017-001181-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 6 days
Research summary
LY3314814, also known as AZD3293, is an investigational medicinal product thought to be helpful in treating people with Alzheimer’s disease (AD). LY3314814 works by stopping the activity of an enzyme (protein) which consequently prevents the build-up of amyloid plaques in the brain. It is hoped that LY3314814 will slow disease progression in people with early-stage AD.
LY3314814 has been evaluated following single oral doses of 1 to 750 mg. This study will be the first time LY3314814 will be administered by intravenous infusion (i.e. Through a plastic tube inserted into a blood vessel).
The aims of this Study are to determine:
•The amount of LY3314814 that gets into the bloodstream from the 2 different formulations (tablet and intravenous [IV] infusion).
•The safety of the 2 different formulations of LY3314814 and any side effects that might be associated with them.
•How long it takes the body to remove the 2 different formulations of LY3314814 and its breakdown products.
Up to 8 subjects may be enrolled and dosed to ensure that at least 6 subjects complete the study. On Day 1 (day of dosing), following an overnight fast of at least 8 hours, participants will receive a single oral dose of 50 mg LY3314814 and at approximately the same time an IV infusion of approximately 100 µg [13 C4 15 N3]-LY3314814 will be started.The infusion will run for 2 hours.Blood samples will be collected pre-dose and up to 120 hours post-dose to measure LY3314814, and [13 C4 15 N3]-LY3314814 concentrations. During the infusion and for at least 4 hours post-infusion, the blood samples will be taken from the arm contralateral to the infusion site. A follow-up visit will occur at least 7 days post-dose.
Safety and tolerability will be assessed throughout the study by means of vital sign measurements, clinical laboratory tests, ECGs,physical examinations(as indicated),and Adverse Event recording.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
17/NW/0411
Date of REC Opinion
9 Nov 2017
REC opinion
Further Information Favourable Opinion