Phase 1, Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Males
Research type
Research Study
Full title
A Phase 1, Open-Label, Two-Part Study of the Disposition and Absolute Bioavailability of [14C]-LY3473329 in Healthy Male Participants
IRAS ID
1007862
Contact name
Eli Lilly
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
Summary of Research
The study drug, LY3473329 is a small molecule that interacts with low density lipoproteins (LDLs) responsible for producing the lipoprotein complex known as Lipoprotein A [Lp(a)]. High levels of Lp(a) have been linked with worsening cardiovascular disease outcomes. It is thought that LY3473329 will disrupt the formation of Lp(a), thus reducing the rate of heart disease in patients at risk.
This trial is a phase 1, open-label, single dose study in healthy male participants. The study will consist of two parts.
Part 1 of this study aims to determine how much of the study drug and its breakdown products get into the bloodstream, urine, faeces and/or expired breath following a single oral solution dose of LY3473329 (Dose 1), containing a small radio-labelled component (Dose 1R).
Part 1 will have about 8 participants. Following a screening visit, participants who qualify for the study may continue with 1 in-clinic visit lasting a minimum of 15 days or a maximum of 30 days, as well as 1 follow-up telephone call about 7 days after discharge from the clinic.Part 2 will aim to compare the amount of Study Drug that gets into the bloodstream, urine and faeces when given by mouth and when given directly into the vein (intravenously). As such the study will involve a dose of oral non-radiolabelled LY3473329 (Dose 2), followed by administration of a radiolabelled IV dose of [14C]-LY3473329 (Dose 2R).
Part 2 will have approximately 8 participants. Following screening, participants will have 1 in-clinic visit lasting 10 days, as well as 1 follow-up telephone call about 7 days after discharge from the clinic.
Summary of Results
This is a Phase 1 study and the results are not required to be posted publicly for early phase study based on UK regulation. The study has been registered on the clinicaltrials.gov public registry (Study Details | A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants | ClinicalTrials.gov). The results that do not include a lay summary will be disclosed on the ct.gov site 30 days after marketing authorisation or 1 year after program termination.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0152
Date of REC Opinion
16 Oct 2023
REC opinion
Further Information Favourable Opinion