Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in healthy Japanese participants. The study will also assess how fast LY3473329 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to about 71 days, inclusive of screening period.
Interventions
DRUGLY3473329
Administered orally.
DRUGPlacebo
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined through medical history and physical examination. * Are males who agree to follow contraception requirements or females not of childbearing potential. * Are 1st generation Japanese defined as the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
Exclusion criteria
* Have a history or presence of medical illness. * Have significant history of or current psychiatric disorders. * Have abnormalities in the 12-lead ECG and blood pressure. * Have received treatment with siRNA within the past 12 months or any antisense oligonucleotide within the past 6 months for lipoprotein(a) \[Lp(a)\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Day 43 | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329 | Predose on Day 1 through Day 43 | PK: AUC of LY3473329 |
| PK: Maximum Concentration (Cmax) of LY3473329 | Predose on Day 1 through Day 43 | PK: Cmax of LY3473329 |
| PK: Time to Maximum Concentration (Tmax) of LY3473329 | Predose on Day 1 through Day 43 | PK: Tmax of LY3473329 |
Countries
United States
Outcome results
None listed